Patients who undergo open-heart surgery and other cardiopulmonary operations where the Stockert 3T heater-cooler system is used, may be at risk for contamination by Mycobacterium chimaera, a bacteria that research shows may grow in the device’s water tanks and be released into the operating room through the heater-cooler’s exhaust vent. If you have been diagnosed with a nontuberculous mycobacteria (NTM) infection, and you believe the Stockert 3T system to be at fault, consult an experience product liability lawyer today to discuss your legal options. You may have grounds to file a product liability lawsuit against Stockert 3T maker LivaNova, in order to pursue the financial compensation you deserve for your injuries, medical expenses, pain and suffering, and other damages.
The Stockert 3T heater-cooler system is a medical device used to regulate the patient’s body temperature during cardioplegic surgeries that stop the heart and blood flow, such as transplant surgeries or cardiac bypass surgeries. The Stockert 3T system uses a closed-water circuit with three separate water tanks to regulate the temperature of oxygenators, bypass machines, heating or cooling blankets, and other equipment designed to keep blood at the optimal temperature for patients undergoing such operations. Approved by the FDA in 2006, the Stockert 3T was originally developed by the Sorin Group, which merged with another European medical device maker in 2015, to become what is now LivaNova.
The side effect most often associated with the Stockert 3T heater-cooler system is a nontuberculous mycobacteria (NTM) infection, which can cause serious illness or possibly even death. The most common symptom of this type of infection, possibly caused by exposure to invasive Mycobacterium chimaera, is unexplained fever, which can take several months or even years to develop, depending on how slowly the bacteria grows. Other possible symptoms of a nontuberculous mycobacteria infection include the following:
Diagnosing a nontuberculous mycobacteria infection can be challenging, because the infection has a long incubation period before symptoms begin to arise, and the infection is also difficult to successfully treat, the mortality rate being nearly 50%. In many cases, an infected patient requires a second surgery to remove an implant that may have become contaminated with M. chimaera during the original operation.
Nontuberculous mycobacterium are organisms that exist in the environment in water and soil and don’t normally pose a risk to human health. However, research has shown that the Stockert 3T heater-cooler system may put patients at risk for infections caused by NTM, due to the use of water tanks, which provide the unit with temperature-controlled water. Although the water in the tanks never actually comes in contact with patients, the water can turn into a gas and pass through the device’s exhaust vent, thereby entering the otherwise-sterile operating room. If the water contains the M. chimaera bacteria, it can spread through the air and contaminate sterile equipment, the patient’s chest cavity, and any implants, such as new valves or vascular grafts, possibly causing an NTM infection. This type of infection poses a serious risk for people who are ill, have compromised immune systems or chronic diseases, and may therefore be more susceptible to infection, and of the 32 cases of M. chimaera reported to the FDA between 2010 and 2015, all involving patients who underwent surgeries using the Stockert 3T system, nearly half of the patients died.
June 2016 – A product liability lawsuit is brought against LivaNova and WellSpan Health, the owner of York Hospital in Pennsylvania, where patient Vincent Karst allegedly contracted a mycobacterial infection during open-heart surgery where the Stockert 3T system was used.
June 2016 – A second complaint filed against LivaNova and WellSpan Health involves the wrongful death of 62-year-old David Inners, who died from a mycobacterial infection nearly one year after undergoing surgery with a Stockert 3T heater-cooler system at York Hospital in Pennsylvania.
July 2016 – A South Carolina man files a product liability lawsuit against LivaNova after undergoing an aortic valve replacement and cardiac bypass grafting procedure in 2014, during which the Stockert 3T system was used to cool and re-warm his blood. He did not experience any initial symptoms, but eventually developed a fever, weakness and pneumonia that was attributed to NTM.
July 2015 – The FDA issues a recall of the Stockert 3T heater-cooler system, indicating that the medical device is associated with a “potential colonization of organisms, including Mycobacteria,” and instructing hospitals and other healthcare facilities that own Stockert 3T heater-cooler systems to maintain them with a new set of guidelines.
October 2015 – A safety communication issued by the FDA highlights the potential risk of mycobacteria infections from surgeries using heater-cooler devices like Stockert 3T, and indicates that between January 2010 and August 2015, the agency received 32 adverse event reports of “patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination.”
October 2015 – The CDC issues a similar safety notice identifying “a need for increased vigilance for NTM infections” associated with heater-cooler devices used during cardiac surgical procedures.
November 2015 – Penn State Milton S. Hershey Medical Center notifies 2,300 patients about the potential for contaminated heater-cooler devices to spread bacteria.
December 2015 – The Pennsylvania Department of Health issues a warning regarding the risk of nontuberculous mycobacterium infections among patients undergoing open heart surgeries on cardiopulmonary bypass.
January 2016 – The FDA issues a warning letter to the Sorin Group, revealing safety violations uncovered during an inspection of the company’s production facilities in Germany and Colorado.
July 2016 – Another safety announcement issued by the FDA warns about Mycobacterium chimaera and the potential for the Stockert 3T to spread the bacteria during surgery, possibly causing “infections in very ill patients, including those with compromised immune systems, and chronic diseases or health conditions.”
October 2016 – The FDA issues an updated warning to patients and hospitals regarding recommendations on how to prevent the spread of infection.
May 2011 – A study of patients facing nontuberculous mycobacterial infections published in the European Respiratory Journal reports that the average treatment course was 14 months, and the average cost $4,916.
March 2015 – Researchers find six male patients between the ages of 49 and 64, with prosthetic valve endocarditis or vascular graft infections from M. chimaera bacteria. The bacteria is also found in heater-cooler units used during the patients’ open-chest heart surgeries.
July 2015 – The journal Clinical Infectious Diseases publishes research highlighting “Invasive Mycobacterium chimaera infections […] diagnosed in 2012 in 2 heart surgery patients on extracorporeal circulation.” The researchers warn in their conclusion about the “airborne transmission of M. chimaera from contaminated heater-cooler unit water tanks to patients during open-heart surgery.”
October 2015 – Ten patients with Mycobacterium chimaera infections are identified at three European hospitals, all of whom underwent open-heart surgery procedures using heater-cooler systems, according to a study published in the European Heart Journal.
October 2015 – An article published by the New York Times details the cases of at least eight patients who developed an infection from a heater-cooler device used during open-heart surgery at a hospital in York, Pennsylvania, four of whom died.
November 2015 – York Hospital in Pennsylvania notifies about 1,300 of its open-heart surgery patients that they could have been exposed to harmful bacteria during their procedure, between October 2011 and July 2015.
February 2016 – An article published by National Geographic highlights the “hidden epidemic of fatal infections linked to heart surgeries” allegedly caused by “spray from the fan of a heater-cooler device used to control the temperature of blood during a cardiac bypass, which contaminates both the otherwise-sterile operating field, and also any implants – a new valve, a vascular graft, being placed in or around the heart.”
February 2016 – Physicians working at the University of Iowa publicize one of their own patients who underwent cardiothoracic surgery at their hospital and subsequently developed an infection due to Mycobacterium chimaera.
June 2016 – Using smoke-dispersal techniques and video observation, researchers find that bacteria particles can travel from the ventilator of the heater-cooler system and enter the surgical area, where they can infect the patient.
LivaNova currently manufactures 60% of all heater-cooler devices on the market, and lawsuits brought against LivaNova for Mycobacterium chimaera infections and other serious side effects accuse the medical device maker of:
More than 250,000 heart bypass procedures are performed by doctors every year, and more than 60% of these procedures use the Stockert 3T device, the most popular heater-cooler system for cardiac surgeries. Unfortunately, a growing body of research published in recent years shows that patients who undergo open-heart surgery and other operations where the Stockert 3T unit is used to regulate body temperature may be at risk for nontuberculous mycobacteria infections caused by exposure to Mycobacterium chimaera. If you believe you have been adversely affected by side effects of exposure to bacteria from a contaminated Stockert 3T heater-cooler device, contact a knowledgeable product liability lawyer today to explore your possible compensation options.