The bodies of open-heart surgery patients cannot afford external stressors; however, the Stöckert 3T heater-cooler device, which is designed to control patients’ blood temperature during cardiac surgery, is doing just that.
Heater-cooler devices, which are used in over 250,000 open-heart surgeries per year in the United States, are designed to keep patients’ circulating blood and organs at a specific temperature during the procedure. The water tanks of the heater-cooler devices provide cooling or warmth to patients’ bodies through the exchange of temperature-controlled water to heat exchangers or blankets.
The water does not come into direct contact with patients; however, contaminated water may enter other parts of the device and aerosolize. This leads to the transmission of bacteria through the device’s exhaust vent—into the air and into the patients’ environment.
The Stöckert 3T heater-cooler device is used in approximately 60% of open-heart surgeries, which puts approximately 150,000 open-heart surgery patients at risk per year.
The Stöckert 3T heater-cooler device has been linked to nontuberculous mycobacteria (NTM) infections, specifically Mycobacterium chimaera. M. chimaera is a species of NTM which is often found in soil and water, and rarely causes sickness; however, open-heart surgery patients are vulnerable to infection.
To make diagnosis more difficult, M. chimaera is extremely slow growing, and there is currently no test to determine whether a person has been exposed to the bacteria. Laboratory cultures can be taken, but may take up to two months to rule out or identify infection.
M. chimaera is difficult to diagnose, symptoms may take months to develop. Also, when symptoms do develop, they are often non-specific, leading to missed of delayed diagnoses, sometimes for years.
Patients who have undergone open-heart surgery should seek medical care if they are experiencing any of the following symptoms:
So far, the FDA has received over 90 adverse event reports, including 79 incidents of infection and 12 associated deaths. These reports all came to the FDA between January 2010 and August 2016. Patients are now filing lawsuits against LivaNova, the manufacturer of the Stöckert 3T heater-cooler device.
If you’ve had open-heart surgery, and believe you have contracted a M. chimaera infection, our Indianapolis defective medical device lawyers can help. Contact Wilson Kehoe Winingham today to schedule a free consultation and discuss your symptoms.
Fill out the form below to receive a free and confidential initial consultation.