#Heater cooler systems for open-heart surgery

[octopusmedical]

Heater Cooler Systems Manufacturer and Supplier in India: Octopus Medical Pvt Ltd 

Heater cooler systems play a crucial role in cardiovascular surgeries, ensuring proper temperature regulation of a patient’s blood during complex procedures. In India, Octopus Medical Pvt Ltd stands as a leader in manufacturing and supplying top-quality heater cooler systems, catering to hospitals, clinics, and medical facilities across the country. 

Why Heater Cooler Systems Matter 

During major surgical procedures, such as open-heart surgeries, maintaining the right body temperature is essential for patient safety and successful outcomes. Heater cooler systems regulate blood and organ temperatures, ensuring stability during these operations. They provide a controlled environment that prevents hypothermia and other temperature-related complications. This life-saving equipment is indispensable in modern medical procedures. 

Octopus Medical Pvt Ltd: A Trusted Name 

Octopus Medical Pvt Ltd has emerged as one of the most reliable and innovative heater cooler system manufacturers and suppliers in India. With years of experience in the medical device industry, they offer world-class equipment designed to meet the stringent demands of critical healthcare environments. Octopus Medical is known for its commitment to precision, safety, and performance, ensuring that their products meet the highest standards of quality. 

Key Features of Octopus Medical Heater Cooler Systems 

Advanced Temperature Control Technology: Octopus Medical’s heater cooler systems use cutting-edge technology to deliver precise temperature control, ensuring that patient blood temperatures are maintained effectively throughout surgeries. 

Durable and Compact Design: The systems are designed with durability in mind, making them reliable for long-term use in demanding medical environments. Their compact design allows for easy installation in operating rooms without occupying excessive space. 

Energy-Efficient: Octopus Medical’s systems are energy-efficient, minimizing power consumption while maintaining peak performance. This feature is critical for hospitals looking to reduce operational costs without compromising on patient care. 

Easy to Use and Maintain: These systems are user-friendly, with intuitive controls that allow medical staff to monitor and adjust temperatures effortlessly. Moreover, they require minimal maintenance, reducing downtime and ensuring continuous operation in critical situations. 

Safety Features: Octopus Medical incorporates various safety features into their systems, such as automated alarms for temperature fluctuations, ensuring that any irregularities are addressed promptly. 

Commitment to Quality and Innovation 

At Octopus Medical Pvt Ltd, innovation and quality go hand-in-hand. The company invests heavily in research and development to ensure that its products remain at the forefront of medical technology. Their heater cooler systems undergo rigorous testing and quality control processes to guarantee reliability and safety. 

Octopus Medical is committed to providing the best-in-class equipment that healthcare providers can trust. By collaborating with healthcare professionals, the company continually refines its product offerings to meet evolving medical needs. 

Why Choose Octopus Medical Pvt Ltd? 

Trusted Manufacturer: Octopus Medical is a trusted name in the Indian medical device industry, known for manufacturing high-quality, reliable heater cooler systems. 

Global Standards: Their products are designed and manufactured according to international medical device standards, ensuring optimal performance in critical healthcare applications. 

Customer Support: Octopus Medical offers excellent after-sales support, providing maintenance services and technical assistance to ensure their equipment remains in top condition. 

Conclusion 

When it comes to heater cooler systems in India, Octopus Medical Pvt Ltd is a name you can trust. With its cutting-edge technology, focus on safety, and commitment to excellence, Octopus Medical is the go-to manufacturer and supplier for healthcare facilities looking for reliable, efficient, and advanced heater cooler systems. 

[lezdotechmed]

Heater-Cooler Infection: Heater-Cooler Devices' Regrettable Hazards

Nontuberculous mycobacteria (NTM) is a microorganism that can cause serious, potentially fatal diseases. Due to their weakened immune systems, patients having cardiothoracic procedures are especially vulnerable. A specific form of bacteria called NTM has been directly connected to heater-cooler units.

Even though the water used in the heat exchanges may not always be contaminated with hazardous bacteria, there has been another important problem that has raised the possibility of serious infection. In the water inside the tank, there is a chance that bacteria will develop. Even though it doesn't directly contact the sufferer, this substance enters the surrounding air. The potential pathogen enters the patient's body through the surgical field, which is sterile because the patient's chest is exposed throughout the procedure.

The FDA released a safety communication in 2015, warning the general public and medical professionals about a severe, perhaps lethal strain of bacteria linked to heater-cooler products.

Claims against the Sorin Group and its affiliates are made in the Sorin Stöckert 3T Heater-Cooler cases. LivaNova PLC and Cyberonics Inc. are included in this. Heater-Cooler infection cases are based on the idea that the maker ought to have been aware that their product might spread bacteria and result in fatal diseases.

The 3T heating and cooling system, manufactured by LivaNova PLC, is still facing legal action because it may increase the risk of heater-cooler infections in patients who have had heart surgery. The complaints contend that LivaNova failed to alert hospitals and doctors to these dangers. When a person, team, or employer acts irresponsibly and injures another, this is negligence.

In federal court, there are multiple Sorin Stockert 3T Heater lawsuits that are still active. Multidistrict litigation involving these cases is currently taking place in the Eastern District of Pennsylvania. There were 135 cases filed as of May 2018, but the number is still rising and will continue to do so because the infection can take years to manifest. The lawsuits that are currently pending in federal court have been discussed as potential settlements.

The Sorin 3T units are accused in the product liability lawsuits of having a significant design flaw that makes them encourage the growth and spread of bacteria on patients during operations involving an open chest cavity.

You might be eligible to file a lawsuit if you or a loved one underwent a procedure that involved the Stockert 3T device and afterwards developed a bacterial heater-cooler infection. You may also be entitled to damages, which could include, past and future medical costs, pain and suffering, emotional anguish, wage loss, and wrongful death (if an infection caused a loved one's passing).

Your injuries, their circumstances, and the treatment and therapy you need will all affect how much compensation you get for an accident caused by a poor medical device. The medical record review services offered by LezDo techmed make it simple for attorneys to identify the benefits and drawbacks of the heater-cooler cases. From our site, you can read more blogs like, singulair lawsuits, Unilever dry shampoo recall and insulin pump lawsuits.

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[lindamcsherry]

Heart Surgery Infection Settlement Results in $225M Payment Over 3T Heater Cooler Contamination

Livanova has agreed to pay $225 million to settle most heart surgery infection lawsuits filed over problems with 3T Heater-Cooler systems commonly used in recent years during cardiac procedures, which were contaminated and caused devastating infections that could surface months or years later.

The manufacturer issued a press release on March 29, announcing that it had reached an agreement to resolve about 75% of the pending cases filed nationwide in recent years. The settlement involves a total payment of up to $225 million, with $135 million paid no earlier than July 2019, and the rest paid in January 2020.

It is unclear how many cases are resolved in the deal, but there are currently at least 85 product liability lawsuits pending in the federal court system, which are centralized before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, as part of an MDL, or multidistrict litigation.

Each of the complaints filed in recent years raise similar allegations, indicating that certain 3T Heater-Cooler Systems were contaminated, releasing a mist into the air of operating rooms during open heart surgery, which has allegedly caused plaintiffs to develop serious and life-threatening infections following heart surgery.

Livanova notes that it had established a reserve of $294 million in the fourth quarter to pay for the ongoing 3T Heater Cooler litigation.

“We believe entering into the settlement is in the best interest of the Company, its shareholders and patients, because it will remove ongoing costs and uncertainty as we focus on executing our strategy to deliver quality care to patients around the world,” Damien McDonald, Chief Executive Officer of LivaNova, said in the press release.

The agreement does not include an admission of guilt by Livanova.

3T Heater Cooler Infection Risks

The Sorin 3T Heater-Cooler designed to help regulate blood temperature. However, concerns over the safety of the devices emerged in late 2015, when the FDA warned about reports of heart surgery infections linked to heater-coolers, indicating that a large number of adverse event reports had been received by the agency.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

The post Heart Surgery Infection Settlement Results in $225M Payment Over 3T Heater Cooler Contamination appeared first on AboutLawsuits.com.

[cassandradodds]

Lawsuits Filed over LivaNova Stöckert 3T Heater-Cooler Infections

LivaNova Sued Over NTM Infections from Heater-Cooler Devices

LivaNova, formerly known as Sorin Group, has been facing contamination concerns associated with its Stöckert 3T Heater-Cooler Devices for several years. Now, the company is facing lawsuits alleging that their heater-cooler devices caused nontuberculous mycobacterium (NTM) infections in patients undergoing open-heart surgery. Regulators, including the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), have warned about this risk.

Parker Waichman LLP is a national law firm with decades of experience representing clients in medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a LivaNova (formerly known as Sorin Group) Stöckert 3T heater-cooler device lawsuit.

Heater-cooler devices are used during surgery to maintain a patient’s body temperature. The system contains a closed water circuit, which does not contact the patient. However, bacteria living in the water circuit can contaminate the sterile environment of the operating room through the exhaust vent. Many patients affected by this issue suffered an infection caused by a type of NTM called Mycobacterium chimaera (M. Chimaera). Symptoms of NTM infection include an unexplained fever, night sweats, fatigue, joint or muscle pain, nausea, difficulty breathing and redness, heat or pus at the surgical incision site.

LivaNova is facing a growing number of lawsuits alleging NTM infections from Stöckert 3T heater-cooler system. Plaintiffs are generally people who underwent heart surgery with the machines; some sued after receiving letters from hospitals warning them of a possible infection. NTM infections are slow-growing, and hard to treat. Patients may not know they have an infection until months or even years after the surgery. According to court records, one woman filed a wrongful death claim on behalf of her deceased husband, who underwent a cardiac bypass procedure in March 2014.

Both individual personal injury lawsuits and class action lawsuits have been filed. A class action lawsuit represents an entire group of plaintiffs.

Stöckert 3T Heater-Cooler Infection Background

The Stöckert 3T heater-cooler device was approved in 2006. Sorin Group, which has since merged with another company to become LivaNova, initially developed the 3T. The 3T heater-cooler system contains three separate tanks of water used to regulate devices that ultimately maintain a patient’s blood and body temperature. The device is used in surgeries where the heart and blood flow is stopped, such as heart transplant surgeries and cardiac bypass surgeries.

According to the FDA, heater-cooler devices can spread NTM infections when the bacteria are aerosolized, or transmitted through the air. The agency received 32 reports of M. chimaera infections associated with 3T heater-cooler devices between 2010 and 2015. In nearly half these patients, the infections were fatal.

Normal, healthy individuals are usually not affected by NTM. The bacteria are normally present in our environment. However, the consequences can be serious in open-heart surgery patients, who are susceptible to illness. When the bacteria aerosolize, they can contaminate sterile equipment, medical devices, or enter the patient’s open chest directly.

Parker Waichman notes that heater-cooler devices have been linked to NTM infections for several years.

In November 2016, the Infection Control & Hospital Epidemiology, the journal of the Society for Health Epidemiology of America, published a study linking the devices to NTM infections.

The lead author of the study is Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland. “It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world,” Dr. Sommerstein said. “Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”

“While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling and risk mitigation still require clarification,”

The manufacturer discovered M. chimaera contamination on the production line and water supply at the heater-cooler facility in August 2014. That September, the company added cleaning and disinfection procedures on the production line to address the contamination.

The FDA issued a Safety Communication update in October 2016 regarding 3T heater-cooler systems. Regulators issued guidelines to help prevent NTM infections from spreading. Among other things, the FDA said to isolate and remove any contaminated devices from health care facilities. When using a different heater-cooler system, new equipment should be used in conjunction with it. The FDA also said that the heater-cooler exhaust should be directed away from the patient and towards the operating room exhaust vent.

At around the same time, the Centers for Disease Control and Prevention (CDC) also issued a health advisory “advising hospitals to notify patients who underwent open-heart (open-chest) surgery involving a Stöckert 3T heater-cooler that the device was potentially contaminated, possibly putting patients at risk for a life threatening infection. New information indicates that these devices, manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), were likely contaminated with the rare bacteria Mycobacterium chimaera during manufacturing.”

In Spring of 2015, contaminated heater-cooler devices were linked to NTM infections in six Swiss patients. That July, a Pennsylvania hospital also identified a group of infected patients. The CDC helped conduct an investigation linking the infections to contaminated heater-cooler systems. Using whole-genome sequencing, researchers at the CDC and National Jewish Health found that the NTM infections in the patients and devices were highly related. “This evidence for likely point-source contamination of the 3T heater-cooler devices is consistent with recent reports from Europe that describe matching of M. chimaera sequences from environmental isolates at the device production site in Germany and isolates from patients and devices in Europe,” the CDC said in its health advisory.

Each year in the United States, heater-cooler devices are used in over 250,000 heart bypass procedures. The CDC says LivaNova’s 3T heater-cooler linked to the infections accounts for about 60 percent of all heater-cooler systems in the country.

Filing a Stöckert 3T Heater-Cooler Lawsuit

If you or someone you know suffered an infection after undergoing surgery involving a LivaNova (formerly Sorin Group) Stöckert 3T heater-cooler device, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information about filing a Stöckert 3T heater-cooler lawsuit, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-filed-livanova-stockert-3t-heater-cooler-infections/

from WordPress https://parkerwaichman.wordpress.com/2017/05/05/lawsuits-filed-over-livanova-stockert-3t-heater-cooler-infections/

[parkerwaichmanlaw]

Lawsuits Filed over LivaNova Stöckert 3T Heater-Cooler Infections

LivaNova Sued Over NTM Infections from Heater-Cooler Devices

LivaNova, formerly known as Sorin Group, has been facing contamination concerns associated with its Stöckert 3T Heater-Cooler Devices for several years. Now, the company is facing lawsuits alleging that their heater-cooler devices caused nontuberculous mycobacterium (NTM) infections in patients undergoing open-heart surgery. Regulators, including the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), have warned about this risk.

Parker Waichman LLP is a national law firm with decades of experience representing clients in medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a LivaNova (formerly known as Sorin Group) Stöckert 3T heater-cooler device lawsuit.

Heater-cooler devices are used during surgery to maintain a patient’s body temperature. The system contains a closed water circuit, which does not contact the patient. However, bacteria living in the water circuit can contaminate the sterile environment of the operating room through the exhaust vent. Many patients affected by this issue suffered an infection caused by a type of NTM called Mycobacterium chimaera (M. Chimaera). Symptoms of NTM infection include an unexplained fever, night sweats, fatigue, joint or muscle pain, nausea, difficulty breathing and redness, heat or pus at the surgical incision site.

LivaNova is facing a growing number of lawsuits alleging NTM infections from Stöckert 3T heater-cooler system. Plaintiffs are generally people who underwent heart surgery with the machines; some sued after receiving letters from hospitals warning them of a possible infection. NTM infections are slow-growing, and hard to treat. Patients may not know they have an infection until months or even years after the surgery. According to court records, one woman filed a wrongful death claim on behalf of her deceased husband, who underwent a cardiac bypass procedure in March 2014.

Both individual personal injury lawsuits and class action lawsuits have been filed. A class action lawsuit represents an entire group of plaintiffs.

Stöckert 3T Heater-Cooler Infection Background

The Stöckert 3T heater-cooler device was approved in 2006. Sorin Group, which has since merged with another company to become LivaNova, initially developed the 3T. The 3T heater-cooler system contains three separate tanks of water used to regulate devices that ultimately maintain a patient’s blood and body temperature. The device is used in surgeries where the heart and blood flow is stopped, such as heart transplant surgeries and cardiac bypass surgeries.

According to the FDA, heater-cooler devices can spread NTM infections when the bacteria are aerosolized, or transmitted through the air. The agency received 32 reports of M. chimaera infections associated with 3T heater-cooler devices between 2010 and 2015. In nearly half these patients, the infections were fatal.

Normal, healthy individuals are usually not affected by NTM. The bacteria are normally present in our environment. However, the consequences can be serious in open-heart surgery patients, who are susceptible to illness. When the bacteria aerosolize, they can contaminate sterile equipment, medical devices, or enter the patient’s open chest directly.

Parker Waichman notes that heater-cooler devices have been linked to NTM infections for several years.

In November 2016, the Infection Control & Hospital Epidemiology, the journal of the Society for Health Epidemiology of America, published a study linking the devices to NTM infections.

The lead author of the study is Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland. “It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world,” Dr. Sommerstein said. “Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”

“While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling and risk mitigation still require clarification,”

The manufacturer discovered M. chimaera contamination on the production line and water supply at the heater-cooler facility in August 2014. That September, the company added cleaning and disinfection procedures on the production line to address the contamination.

The FDA issued a Safety Communication update in October 2016 regarding 3T heater-cooler systems. Regulators issued guidelines to help prevent NTM infections from spreading. Among other things, the FDA said to isolate and remove any contaminated devices from health care facilities. When using a different heater-cooler system, new equipment should be used in conjunction with it. The FDA also said that the heater-cooler exhaust should be directed away from the patient and towards the operating room exhaust vent.

At around the same time, the Centers for Disease Control and Prevention (CDC) also issued a health advisory “advising hospitals to notify patients who underwent open-heart (open-chest) surgery involving a Stöckert 3T heater-cooler that the device was potentially contaminated, possibly putting patients at risk for a life threatening infection. New information indicates that these devices, manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), were likely contaminated with the rare bacteria Mycobacterium chimaera during manufacturing.”

In Spring of 2015, contaminated heater-cooler devices were linked to NTM infections in six Swiss patients. That July, a Pennsylvania hospital also identified a group of infected patients. The CDC helped conduct an investigation linking the infections to contaminated heater-cooler systems. Using whole-genome sequencing, researchers at the CDC and National Jewish Health found that the NTM infections in the patients and devices were highly related. “This evidence for likely point-source contamination of the 3T heater-cooler devices is consistent with recent reports from Europe that describe matching of M. chimaera sequences from environmental isolates at the device production site in Germany and isolates from patients and devices in Europe,” the CDC said in its health advisory.

Each year in the United States, heater-cooler devices are used in over 250,000 heart bypass procedures. The CDC says LivaNova’s 3T heater-cooler linked to the infections accounts for about 60 percent of all heater-cooler systems in the country.

Filing a Stöckert 3T Heater-Cooler Lawsuit

If you or someone you know suffered an infection after undergoing surgery involving a LivaNova (formerly Sorin Group) Stöckert 3T heater-cooler device, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information about filing a Stöckert 3T heater-cooler lawsuit, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-filed-livanova-stockert-3t-heater-cooler-infections/

[abbottlawgroups-blog]

What Jezebel Should Write About Heater Cooler Lawsuits

The U.S. Nourishment and Drug Administration (FDA) as of late discharged a security cautioning for the German-made Stockert 3T Heater Cooler System, which is a restorative gadget normally utilized as a part of healing centers all through the United States amid heart surgeries. This October 2016 cautioning comes after two prior FDA security interchanges, one in June 2016 and one in October 2015, about the radiator cooler gadget's relationship with Mycobacterium fabrication (M. delusion). M. fabrication is a moderate creating type of nontuberculous mycobacterium (NTM), which is a microscopic organisms that can bring about diseases in patients who have had intrusive strategies or who have debilitated insusceptible frameworks.

The lawyers of Abbott Law Group are at present exploring claims in the interest of the individuals who were truly harmed or passed on therefore of building up a contamination in the wake of experiencing surgery in which a Heater cooler lawsuit was utilized. Contact our law office today for a free warmer cooler claim interview.

What is a Heater Cooler?

The Stockert 3T Heater Cooler System, which is the sort of warmer cooler at the focal point of the FDA wellbeing cautioning, is produced in Germany by LivaNova PLC (previously Sorin Group Deutschland GmbH). The gadget is utilized amid heart surgeries to keep a patient's organs and coursing blood at the perfect temperature all through the operation, which has been appeared to enhance results and recuperation time.

The warmer cooler works by transporting the warmed, or cooled, water from the gadget's water repository to outside warmth exchangers or warming covers. While the hardware and the temperature-controlled water don't come in direct contact with the patient, there is the likelihood of the water vanishing or getting splashed into the quality of the working room.

The issue with this is microscopic organisms can develop in the gadget's water repository, so when the water gets into the demeanor of the working room and in this way into the patient's open trunk amid surgery, the patient runs a genuine danger of creating M. delusion.

On the off chance that you or a friend or family member had surgery and along these lines created M. figment or NTM, contact Abbott Law Group today to talk about your legitimate rights.

Warmer Cooler Infection Symptoms

The Stocker lawsuit is utilized as a part of roughly 250,000 heart-sidestep systems in the U.S. every year, and the Stockert 3T Heater Cooler System is utilized as a part of around 60% of these methods. This implies about 150,000 Americans risk creating M. delusion and resulting contaminations subsequent to having a heart surgery. M. delusion and consequent contaminations are hard to analyze on the grounds that the indications are frequently extremely basic of any infection and they regularly happen months and even years not far off, given that it is a moderate creating type of NTM.

A portion of the side effects of radiator cooler contaminations include:

Night sweats

Muscle throbs

Weight reduction

Weakness

Unexplained fever

What exacerbates matters is that there is no test to figure out if a man has been presented to the microscopic organisms. As indicated by the Centers for Disease Control and Prevention (CDC), warmer cooler M. delusion contaminations must be analyzed by developing and breaking down the microbes by research facility culture, however the moderate developing nature of the microscopic organisms can require up to two months to preclude the disease.

Radiator Cooler Infection Lawyers

In the event that you or a friend or family member created M. fabrication or resulting disease in the wake of experiencing heart surgery in which a radiator cooler was utilized, you might be qualified for remuneration for past and future doctor's visit expenses, lost wages, loss of future profit, agony and enduring, corrective harms, and different harms.

In any case, it is essential that you contact our legal counselors at the earliest opportunity as Florida's Statute of Limitations confines the measure of time an offended party needs to document a claim against the gathering in charge of his or her harms.

The lawyers of Abbott Law Group have more than thirty years of experience taking care of individual harm and wrongful passing cases including a faulty or perilous restorative gadget like the Stockert 3T Heater Cooler System. Contact our group of lawyers today for a free radiator cooler claim case assessment.

[jonathanlansford]

Penn Health System, Penn Medicine sued over alleged infections tied to heater-cooler units

Two patients allegedly contracted serious bacterial infection from heater-cooler units used during open-heart surgery.

from Healthcarecare Finance News Feed http://www.healthcarefinancenews.com/news/penn-health-system-penn-medicine-sued-over-alleged-infections-tied-heater-cooler-units

[ellisellenq]

3T Heater-Cooler Systems Lawsuits – What You Need to Know

A number of open heart surgery patients have been shown to have developed severe infections from the non-tuberculous mycobacteria, Mycobacterium chimaera (or M. Chimera). The infection has been shown to be potentially life threatening and has been linked to issues with the 3T Heater-Cooler systems used in operating rooms.

Problematic Heater-Cooler systems

Various machines are used to control the conditions of a patient’s body while they are under general anesthesia during surgery. This helps to improve their medical condition and the outcome of their surgeries. One such machine is a heater-cooler unit. These units are used to control the body temperature of patients during surgery.

The devices include a water tank that supplies water at a specified temperature to blankets or heat exchangers. This provides heating or cooling to the body.

Research on 3T systems have shown that the water used in the system can be contaminated and result in the release of bacteria through the system’s exhaust vents. When these bacteria come into contact with patients, they cause infections.

The Journal of Clinical Microbiology published a case report in 2013 detailing two cases in which heart surgery patients developed infections caused by M. chimera. No connection was made to the 3T systems that were used at the time. However, when the bacteria were discovered in the water supply and production line of the manufacturing facility, the connection became clear.

A more recent study published in June 2016, reported ten cases of heart surgery patients that had developed M. Chimera infections. The Food and Drug Administration (FDA) issued a safety communication in the same month. The warning cited the risk of developing M. chimera infections when 3T heater-cooler systems were used in open heart surgeries.

Hospitals have since been required to take steps to remove the heater-cooler devices, connectors and tubing that tests positive for the bacteria. They are also required to monitor patients who have undergone surgery for signs of infection. These include:

Infection at the surgical site

Bacteremia

Hepatitis

Abscess

Osteomyelitis

Endocarditis

Renal insufficiency

3T Heater-Cooler Lawsuits and M. Chimera Infections

Patients and loved ones are now filing claims against the manufacturers of the 3T system, LIvaNova PLC. This is because the device has been directly linked to the transmission of bacteria to patients during surgery.

The challenge in filing the claims is that many of the symptoms of the infections take several months and even years to develop. Some patients who had been exposed have also died as a result of the complications.

Be sure to talk to an experienced medical device attorney if you or someone you know has experienced heart surgery and subsequently suffered an M. Chimera infection.

Related article:

www.usrecallnews.com/3t-heater-cooler-system-surgical-infections

3T Heater-Cooler Systems Lawsuits – What You Need to Know published first on https://fergusonlawatty.wordpress.com

[joyjalvarez]

3T Heater-Cooler Systems Lawsuits – What You Need to Know

A number of open heart surgery patients have been shown to have developed severe infections from the non-tuberculous mycobacteria, Mycobacterium chimaera (or M. Chimera). The infection has been shown to be potentially life threatening and has been linked to issues with the 3T Heater-Cooler systems used in operating rooms.

Problematic Heater-Cooler systems

Various machines are used to control the conditions of a patient’s body while they are under general anesthesia during surgery. This helps to improve their medical condition and the outcome of their surgeries. One such machine is a heater-cooler unit. These units are used to control the body temperature of patients during surgery.

The devices include a water tank that supplies water at a specified temperature to blankets or heat exchangers. This provides heating or cooling to the body.

Research on 3T systems have shown that the water used in the system can be contaminated and result in the release of bacteria through the system’s exhaust vents. When these bacteria come into contact with patients, they cause infections.

The Journal of Clinical Microbiology published a case report in 2013 detailing two cases in which heart surgery patients developed infections caused by M. chimera. No connection was made to the 3T systems that were used at the time. However, when the bacteria were discovered in the water supply and production line of the manufacturing facility, the connection became clear.

A more recent study published in June 2016, reported ten cases of heart surgery patients that had developed M. Chimera infections. The Food and Drug Administration (FDA) issued a safety communication in the same month. The warning cited the risk of developing M. chimera infections when 3T heater-cooler systems were used in open heart surgeries.

Hospitals have since been required to take steps to remove the heater-cooler devices, connectors and tubing that tests positive for the bacteria. They are also required to monitor patients who have undergone surgery for signs of infection. These include:

Infection at the surgical site

Bacteremia

Hepatitis

Abscess

Osteomyelitis

Endocarditis

Renal insufficiency

3T Heater-Cooler Lawsuits and M. Chimera Infections

Patients and loved ones are now filing claims against the manufacturers of the 3T system, LIvaNova PLC. This is because the device has been directly linked to the transmission of bacteria to patients during surgery.

The challenge in filing the claims is that many of the symptoms of the infections take several months and even years to develop. Some patients who had been exposed have also died as a result of the complications.

Be sure to talk to an experienced medical device attorney if you or someone you know has experienced heart surgery and subsequently suffered an M. Chimera infection.

Related article:

www.usrecallnews.com/3t-heater-cooler-system-surgical-infections

3T Heater-Cooler Systems Lawsuits – What You Need to Know published first on http://helloinjuryhelpnowposts.tumblr.com

[lindamcsherry]

Heart Surgery Infection Settlements To Be Discussed in Litigation Over 3T Heater-Coolers

The U.S. District Judge overseeing all 3T Heater Cooler System heart infection lawsuits filed in federal courts nationwide has appointed a settlement master to oversee ongoing negotiations aimed at resolving the litigation, avoiding the need for dozens of individual cases to go before juries nationwide. 

There are currently at least 85 product liability lawsuits filed against the manufacturers of the Sorin 3T Heater-Cooler in the federal court system, each raising similar allegations that the surgical devices were contaminated, releasing a mist into the air of operating rooms during open heart surgery, which has allegedly caused plaintiffs to develop serious infections that may not surface until months, or even years, after the procedure.

Given similar questions of fact and law presented in the cases, the claims have been centralized as part of a federal multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

As product liability lawyers continue to review and file complaints for individuals who developed nontuberculous mycobacterim (NTM) infections following exposure to contaminated 3T Heater-Coolers used during open heart surgery, it is ultimately expected that there may be several hundred cases involved in the litigation.

In a case management order (PDF) filed on December 3, Judge Jones appointed Randi Ellis to work as a special master in the litigation, to explore possible heart surgery infection settlements. The order requires the parties to meet and confer on a monthly basis with Ellis to work toward a settlement agreement, and Ellis will report any progress back to the Court.

The order notes that Ellis is a member of the Academy of Court Appointed Special Masters, and has served in that capacity in numerous federal and state cases. Plaintiffs and defendants have been ordered to split her fees evenly.

3T Heater Cooler Infection Risks

The Sorin 3T Heater-Cooler is a medical device commonly used during cardiac surgery and other procedures to help regulate blood temperature. However, litigation over the heater-coolers emerged after it was discovered that certain devices sold in recent years may have contaminated sterile operating rooms.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

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Heart Transplant NTM Infection Lawsuit Filed Against Makers of 3T Heater-Cooler System

A wrongful death lawsuit recently filed by the widow of a Texas man indicates that a contaminated 3T Heater Cooler System caused a nontuberculous mycobacteria (NTM) infection to develop following heart transplant surgery. 

The complaint (PDF) was filed by Benji Nelson in the U.S. District Court for the Northern District of Texas on October 30, indicating that the widely used heart surgery device increased the risk for complications and infections, which may develop weeks to years later.

Nelson brings the claim on behalf of herself and the estate of her late husband, Terry Nelson, who allegedly was expected to a contaminated 3T Heater-Cooler during a heart transplant in May 2016. The device was used to regulate the temperature of his blood during the procedure, but during the weeks after the surgery he required treatment for crypto pneumonia, recurrent crypto meningitis, nocardia pneumonia and atypiccal mycobacterial infection in the lung.

In September 2016. Terry Nelson was hospitalized and diagnosed with a nontuberculous mycobacteria (NTM) infection. After experiencing acute respiratory failure and other health issues, Nelson was hospitalized again in January 2017 and ultimately died on February 27, 2017, after suffering multi-organ.

Sorin 3T Heater-Coolers are often used during heart bypass surgery, valve replacement surgery and other cardiac procedures. However, in recent years it has been discovered that certain devices manufactured prior to September 2014 were be contaminated with a slow growing bacteria, which may be enter the sterile operating room through vapors released by the devices.

For individuals with compromised immune systems and an open chest cavity during heart surgery, this has resulted in reports of Mycobacterium chimaera or Mycobacterium abscessus infections that surface long after the procedure, all of which are forms of NTM infections like the one that killed Nelson.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

“Defendants knew prior to 2015, and continue to know, that its disclosures to the FDA, the public, and Plaintiff were, and are, incomplete and misleading and that the Sorin 3T System was and is causing numerous patients severe injuries and complications, which violates Federal and State requirements,” Nelson’s lawsuit states. “Defendants suppressed this information and failed to accurately and completely disseminate or share this and other critical information with the FDA, the medical community, health care providers, and patients.”

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Given similar questions of fact and law presented in lawsuits filed nationwide, the dozens of cases filed throughout the federal court system have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

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[lindamcsherry]

Livanova Issues New 3T Heater-Cooler Cleaning Instructions Due to Heart Surgery Infection Risk

Following reports of heart surgery infections linked to contaminated 3T Heater-Coolers in recent years, the manufacturers indicate the blood temperature regulating machines will be redesigned, and new cleaning instructions have been issued for hospitals that are designed to reduce the risk of infections.

Livanova issued a medical device correction letter (PDF) on October 18, providing customers with updated instructions on the monitoring and use of hydrogen peroxide in the 3T heater Coolers to help prevent microbial growth.

The company also announced that it is making changes to the devices’ vacuum canister and internal sealing to prevent the risk of water vapor being emitted as an aerosol into the operating room, which has been identified as a cause of severe and life-threatening infections that may surface months, or even years, after open heart surgeries where the heater-cooler systems were used.

The FDA also issued a safety communication late last week, passing on the Livanova information and indicating that the agency is staying actively involved with the manufacturer.

The U.S. Centers for Disease Control and Prevention (CDC) is also evaluating Livanova’s infection mitigation efforts and conducting its own scientific research, according to the FDA statement, which indicates that the CDC will issue further updates as appropriate.

Sorin 3T Heater-Coolers are commonly found in operating rooms to regulate blood temperature during heart bypass surgery, valve replacement surgery and other cardiac procedures. However, in recent years it has been discovered that certain devices manufactured prior to September 2014 may be contaminated with a slow growing bacteria, which may be enter the sterile operating room through vapors released by the devices.

For individuals with compromised immune systems and an open chest cavity during heart surgery, this has resulted in reports of Mycobacterium chimaera or Mycobacterium abscessus infections that surface long after the procedure.

The FDA first warned about the heart surgery infection risk from heater-cooler devices in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Later that year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air.

“Although the water in the 3T heater-cooler unit does not come into direct contact with the patient, users should be mindful that aerosols are emitted when the 3T is used, primarily during the patient warming phase and at the end of a procedure, when water is returned to the tanks,” Livanova states in the medical device correction letter. “Depending on the characteristics of the bacteria and the concentration of bacteria in the water in the tanks, these aerosols may carry bacteria into the operating room environment. Another risk of contamination for the patient is a direct contact transfer of water/solution droplets containing water-borne, pathogenic microorganisms into the surgical field.”

The letter indicates that users should monitor the hydrogen peroxide concentration in the water solution daily to ensure that there is enough present to fight microbial contamination. The concentration should always remain about 100 parts per million, the letter indicates. It also includes an attachment that has monitoring instructions.

The letter also notes that the company has developed a vacuum canister and internal sealing design change which cuts down on the risk of airborne transmission of NTM. However, it notes that the change would not eliminate the threat entirely.

Customers will be contacted by a company representative to plan the upgrade of affected products.

Livanova faces a growing number of open heart surgery infection lawsuits filed nationwide over the 3T Heater-Cooler, alleging that the manufacturers knew about the risk of contamination and failed to adequately warn the medical community, the FDA, and patients of the risks.

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[lindamcsherry]

Parents Bring Lawsuit Over Child’s Surgical Infection from 3T Heater Cooler

A Louisiana couple indicates that their minor daughter contracted a serious hospital infection due to a contaminated 3T Heater Cooler system used during open heart surgery. 

In a complaint (PDF) filed last week in the U.S. District Court for the Eastern District of Louisiana, Amando Cuellar and Aleyda Romero indicate that tainted systems used to control blood temperature during cardiac surgery exposed their daughter to bacteria which has been linked to reports of similar infections that may surface months or even years later.

The minor child, Valentina Cuellar, underwent open heart surgery in August and September of 2017, at which time a 3T Heater-Cooler was used. Following the procedures, she contracted, and was treated for, mycobacterium abscessus and staphylococcus aureus infections.

According to allegations raised in the lawsuit, Livanova knew for several years about the risk of contamination with it’s 3T Heater-Cooler systems, but failed to provide adequate warnings or take effective actions to address the problem.

“Upon information and belief, by April 2015, [the manufacturer] knew that their ‘enhanced hygiene concept’ was ineffective in eliminating all bacteria, including mycobacteria chimaera, from devices that were not new and/or were already contaminated,” according to the complaint.

The Cuellars raise allegations similar to those presented in dozens of other surgical infection lawsuits filed by individuals nationwide, which claim that devices release contaminated bacteria in a mist into the air of the operating room, which may enter the open surgical wound.

Valentina Cuellar was one of several children diagnosed with infections at the Louisiana Children’s Medical Center, after undergoing heart surgery involving the 3T Heater-Cooler system, according to the lawsuit.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Given similar questions of fact and law presented in lawsuits filed nationwide, the dozens of cases filed throughout the federal court system have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

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[lindamcsherry]

Case Management Plan for 3T Heater-Cooler Infection Cases Proposed in MDL

Parties involved in the federal heart surgery infection lawsuits over 3T Heater-Cooler Systems have proposed a case management plan, which would guide the litigation for the next several months. 

There are currently at least 56 product liability lawsuits filed against the manufacturers of the Sorin 3T Heater-Cooler in the federal court system, each raising similar allegations that the devices were contaminated, releasing a mist into the air of operating rooms during open heart surgery that resulted in the development of serious infections that often do not surface until months, or even years, after the procedure.

Given similar questions of fact and law presented in the cases, the claims have been centralized as part of a federal multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

As product liability lawyers continue to review and file complaints for individuals who developed nontuberculous mycobacterim (NTM) infections following exposure to contaminated 3T Heater-Coolers used during open heart surgery, it is ultimately expected that there may be several hundred cases involved in the litigation.

On June 19, plaintiffs and defendants issued a joint proposed case management order (PDF), setting goals for case-specific and generic discovery over the next 120 days.

The order seeks to have parties agree on the contents of a Plaintiff fact sheet and Defendant fact sheet by the end of the month, as well as agreement on any possible protective order revisions. It also calls for Plaintiff fact sheets to be served 30 days after the court approves of the sheets, and the serving of completed Defendant fact sheets 60 days after that.

In addition, the agenda sets an October 5, 2018 date for plaintiff to conduct depositions of Defendant personnel, beginning discovery of two hospitals, and to begin written discovery and possible depositions of federal regulators, researchers and laboratories that may impact the litigation.

3T Heater Cooler Infection Risks

The Sorin 3T Heater-Cooler is a medical device commonly used during cardiac surgery and other procedures to help regulate blood temperature. However, litigation over the heater-coolers emerged after it was discovered that certain devices sold in recent years may have contaminated sterile operating rooms.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

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[lindamcsherry]

Lawyers Seek Leadership Roles in 3T Heater-Cooler Infection Lawsuits

Following the recent consolidation of all 3T Heater-Cooler infection lawsuits filed throughout the federal court system, an application has been filed by a group of plaintiffs attorneys who seeking leadership roles in the multidistrict litigation (MDL). 

The 3T Heater-Cooler is a medical device commonly used during open heart surgery, which has been linked to reports of nontuberculous mycobacterim (NTM) infections, which may develop months or even years after surgery.

The devices are used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain Sorin 3T Heater-Cooler systems were contaminated with bacteria, which is then released in a mist that may enter the sterile surgical site.

The bacteria may cause difficult to treat internal infections, which typically do not surface until long after exposure. As a result of the risk, hospitals nationwide have sent letters to thousands of heart surgery patients who may have been exposed to a contaminated 3T Heater-Cooler, recommending continued medical monitoring.

There are currently more than 50 product liability lawsuits pending against the makers of the 3T Heater-Cooler, which have all been centralized before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, for coordinated discovery and pretrial proceedings.

On May 15, a group of plaintiffs’ attorneys filed a joint application (PDF), calling for the establishment of a plaintiffs’ leadership group, including the appointment of an attorney as lead and liaison counsel, and the formation of a Plaintiffs’ Executive Committee, consisting of six other attorneys. These attorneys would take certain actions during the litigation that benefit all cases, while each individual plaintiff’s own lawyer would be responsible for deadlines and establishing causation in the separate cases.

The organization of the leadership positions will be discussed at an case management conference scheduled for May 31, according to a proposed agenda (PDF) filed this week.

On May 16, the parties also filed a proposed case management plan (PDF), which addresses the potential consolidation or grouping of cases or issues, the scope of discovery and dispute resolution, proposed protective orders, proposed mediation procedures and other issues.

The plan notes that a number of cases have already been given trial dates throughout 2019 and 2020, by Chief District Judge John A. Jarvey of the Southern District of Iowa, before the claims were consolidated. The plaintiffs request that Judge Jones accelerate case specific discovery in those cases, and maintain the established trial order, but push back the original trial dates.

3T Heater Cooler Infection Risks

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

The post Lawyers Seek Leadership Roles in 3T Heater-Cooler Infection Lawsuits appeared first on AboutLawsuits.com.

[lindamcsherry]

Contaminated Surgical Heater-Cooler Systems Cause Hundreds of Infections Each Year: CDC

Researchers warn that contaminated 3T Heater-Cooler systems may be responsible for nearly 300 invasive infections every year, which may not surface until long after the devices are used during heart surgery or other procedures, suggesting that mandatory reporting policies be implemented for nontuberculous mycobacterial (NTM) infections. 

In the March edition of Emerging Infectious Diseases, a journal published by the U.S. Centers for Disease Control and Prevention (CDC), Swiss researchers investigated how frequently patients undergoing surgery involving a 3T Heater Cooler devices (HCDs) were actually infected due to contaminated devices distributed worldwide in recent years.

The report warns that contaminated surgical heater-cooler systems have led to a “worldwide epidemic” of invasive Mycobacterium chimaera infections, which may remain dormant for months or even years after exposure, before resulting in life-threatening health complications.

Surgical heater-cooler systems are used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain Sorin 3T Heater-Cooler systems found in operating rooms nationwide were contaminated with bacteria, which may then be released in a mist into the operating room, where it may enter the sterile surgical site.

In this new report, researchers note that while Swiss officials were the first to identify the problem in 2014, it is unknown how widespread the surgical heater-cooler infections are on a global scale. To address that, researchers obtained data from a wide variety of sources, including the Swiss National Registry for Cardiac Surgery and the Swiss Federal Office of Statistics.

According to their findings, they estimate that there are 156 to 282 cases per year of new M. chimaera infections caused by contaminated 3T Heater Cooler systems in the 10 major cardiac valve replacement market countries.

“In summary, our data provide an estimate of the global burden of M. chimaera associated with open heart surgery, enabling policy makers to guide actions and to decrease the risk for transmission from HCDs. Our data suggest implementation of systematic lookback approaches in each country where LivaNova 3T HCDs have been used to optimize case finding,” the researchers concluded. “In addition, countries may consider mandatory reporting of invasive nontuberculous mycobacterial infections.”

As a result of the surgical heater-cooler infection risks, hospitals nationwide have sent letters to thousands of heart surgery patients who may have been exposed to a contaminated systems, recommending continued medical monitoring.

3T Heater Cooler Infection Lawsuits

Dozens of product liability lawsuits have been filed against the manufacturer of the device, on behalf of individuals diagnosed with NTM infections following heart surgery where a contaminated heater-cooler may have been used.

Given similar questions of fact and law raised in complaints pending in federal courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation recently established consolidated pretrial proceedings for the cases, centralizing the claims before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts.

In a safety communication issued last year, FDA officials highlighted concerns about the risk. At that time, the CDC also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Over the coming months and years, as additional heart surgery infections may be diagnosed and injury lawyers investigate additional claims, the size and scope of the litigation is expected to increase substantially.

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