The medical community is becoming increasingly concerned over reports of heart surgery bacterial infection, especially in conjunction with the Stockert 3T Heater-Cooler System.

Sometimes called the Sorin 3T Heater-Cooler, the device has been implicated in reports of heart surgery bacterial infection that allegedly resulted in serious illness and several deaths.

Heart surgery bacterial infection reportedly developed for sufferers in the months after their procedure, with experts stating the patients were exposed to bacterial infection as a result of the cardiac heater cooler used. These devices have been reportedly linked with rare non tuberculosis mycobacteria (NTM), also called Mycobacterium chimaera (M. chimaera), which can cause serious illness or even death.

NTM bacteria are naturally occurring organisms normally found in soil and water, with over 150 different species existing. While most of these bacteria do not cause significant harm to humans, the M. chimaera variant has been linked to the reported deadly heart surgery bacterial infection in Stockert 3T Heater-Cooler System patients.

Overview of Heart Surgery Bacterial Infection Development

The Stockert 3T Heater-Cooler System is a medical device that is meant to help maintain a safe body temperature of the patients during surgery, by using two temperature controlled water tanks. While the water in the tanks does not directly touch the patients, the FDA warns “there is potential for contaminated water to enter other parts of the device and aerosolize.”

This means the potentially deadly bacterial cells can be transmitted through the air out of the device’s exhaust vent, and come in contact with the patients undergoing surgery. Both the FDA and CDC have reported the Stockert 3T Heater Cooler devices may have been contaminated with the mycobacterium cells at some point during the manufacturing process.

The contamination was reportedly discovered in September 2014 at the manufacturing facility in Germany. The issue was noted as resolved in July 2015, when the facility was retested and the FDA reported they found no evidence of contamination on 3T devices manufactured after September 2014.

This is still concerning, however, as the CDC reports that cardiac heater cooler medical devices are used in 60% of bypass surgeries conducted in the United States, or approximately 250,000 surgeries in total.

The FDA released its first warning against potential heart surgery bacterial infection in October 2015, with the agency stating that certain heater cooler devices have been linked to 32 injury reports.

The FDA released an updated warning in June 2016, stating the deadly heart surgery bacterial infection reports were linked to the 3T Heater Cooler device manufactured by LivaNova. Several months later, the FDA issued another warning to health officials that recommended how to help prevent the development of heart surgery bacterial infection.

These heart surgery bacterial infection reports have been submitted from residents in Iowa, Michigan, and Pennsylvania from the beginning of 2011 to present. According to the CDC there have been a total of 28 confirmed bacterial infections and 12 patients have died from the infection.

These deadly bacterial infections sometimes do not immediately develop after surgery, so patients who recently underwent heart surgery using the Stockert 3T Heater Cooler device should be wary of unexpected symptoms including:

• Night Sweats
• Muscle Aches
• Weight Loss
• Fatigue
• Sudden Unexplained Fever

Patients who may have developed a potentially deadly heart surgery bacterial infection may be able to file legal action against the manufacturing company. Potential claimants should contact a lawyer to determine eligibility for legal action.