It uses 3 tanks to circulate both heated and cooled water to slow and preserve the heart in cardioplegia or planned, temporary cessation and to warm the body at the same time.
Reports have shown that the Stockert 3T device may be contaminated with Mycobacterium chimaera or other infectious organisms. Once the unit is contaminated, bacteria may be spread through vapor emitted from the machine. This bacteria-laden vapor can be spread into previously sterile surgical rooms and may expose vulnerable surgical patients to potentially deadly bacterial infections.
The U.S. Food and Drug Administration (FDA) received reports of 79 infection events and 12 deaths associated with Stockert 3T use between 2010 and 2016. Stockert 3T’s manufacturer, LivaNova is facing medical injury lawsuits filed by patients or loved ones of those who were exposed to infection and developed complications or died due to a Stockert 3T surgery.
Stockert 3T Heater-Cooler Device Contamination
As early as 2002, scientists in Germany found that Mycobacterium chimaera (M. chimaera) may grow in the Stockert 3T’s water tanks. Once contaminated and filled with water, the exhaust system may emit bacteria-laden vapor which may spread bacteria into a previously sterile surgical environment. It may also present a serious infection risk to vulnerable surgical patients whose health status is already compromised.
Mycobacterium chimaera is a bacteria similar to the same bacteria that causes tuberculosis but in healthy people is generally non-threatening. In patients who are ill or whose immune systems may be compromised, it can pose a serious threat. Patients who are undergoing invasive surgery with the Stockert 3T device, may be at risk of serious infection or death.
In addition, investigations of infection occurrences have shown that some of the devices that have placed patients at risk may have come from the factory already colonized with the M. chimaera organism. European health authorities have found and established a direct link between bacterial strains in ill patients and bacterial strains found and manufacturing facilities in Germany.
Stockert 3T FDA Warnings
In June of 2015, after multiple deaths had been attributed to the Stockert 3T device, a recall was issued for some of the devices. Information accompanying the notice stated that the device posed a potential threat for colonization if proper maintenance and disinfection were not performed.
The company had been previously warned by the FDA and informed that the devices may be subject to a future ban if they were deemed “adulterated” or “misbranded”. This is a possible result that occurs when a manufacturer fails to follow good manufacturing practices known as GMP in its manufacturing, packaging or storage facilities.
In June 2016, an FDA safety alert was issued to healthcare facilities and providers concerning the infection risk of Stockert 3T devices. In October of 2016, the FDA recommended that older Stockert 3T devices be replaced with new units as soon as possible.
Sorin Stockert 3T Infection Symptoms
Each year in the U.S., over 250,000 cardiac bypass procedures are performed and nearly two-third of these have traditionally employed a Stockert 3T device. This means that between 2010 and the 2016 safety alert, 500,000 patients were potentially placed at risk of exposure to a serious infection.
For those who are exposed to M. chimaera and who are at risk of infection, between 1 in 100 to 1 in 1000 will develop an infection. The risk is greatest in patients who have valves or other prosthetic implants and once infected, infections may be fatal in half of all cases, even with aggressive antibiotic treatment.
This type of infection may take months or even years to develop and will often be taken for another illness. Symptoms of infection include:
- Night sweats
- Weight loss
- Muscle aches
- Chronic cough
- Abdominal abscesses
- Lymph node inflammation
- Drainage from wound
In 2015, the U.S. Centers for Disease Control and Prevention (CDC) issued an informational kit to doctors to aid in infection identification but infections are still challenging to treat and may be fatal.
Stockert 3T Infection Lawsuits
LivaNova is facing a number of Stockert 3T for infections, injury and deaths caused by the devices.
The lawsuits claim that LivaNova:
- Manufactured defective devices
- Sold devices which were already contaminated
- Failed to conduct appropriate safety tests
- Failed to provide appropriate procedures for disinfection and cleaning of units
- Failed to warn patients and medical community about risks the device may pose
- Continued to sell devices after problems were discovered
Federal Stockert 3T lawsuits against LivaNova have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Middle District of Pennsylvania but other cases may be pending in state and local courts as well.
Plaintiffs are seeking compensation for damages including medical costs, lost wages, pain and suffering, wrongful death and may be asking for punitive damages.
Patients or loved ones of those who became seriously ill or died after an invasive surgical procedure or cardiac surgery using a Stockert 3T device should seek legal advice.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.