With heart surgery infection risk becoming increasingly prevalent in patients who used the Stockert 3T Heater Cooler System, a class action investigation has been spurred against LivaNova PLC.

Certain Stockert 3T Heater Cooler System models have been linked to an increased heart surgery infection risk, which can be potentially deadly to patients.

The FDA and CDC stated that Stockert 3T Heater Cooler System models manufactured before September 2014 may carry an increased heart surgery infection risk because they may have been contaminated with Mycobacterium chimaera (M. chimaera) bacterium.

This contamination was reportedly discovered when the manufacturing facility was being tested in September 2014, but was reportedly resolved in July 2015. At this time, the manufacturing plant was retested and was confirmed to have no more contamination.

On this note, Stockert 3T Heater Cooler System models manufactured after September 2014 reportedly do not carry an increased heart surgery infection risk.

Overview of Heart Surgery Infection

The M. chimaera bacteria is a type of bacteria that is typically found in water or soil, and is rarely harmful to humans. This changes if the bacterium enters the body through an open surgical wound, which has been increasing the heart surgery infection risk.

The Stockert 3T Heater Cooler System is a medical device that is used to control the temperature of internal organs during cardiac bypass surgeries. Cardiac heater cooler systems are used in approximately 250,000 cardiac bypass surgeries per years, but approximately 60 percent of these devices used in hospitals have been linked to potentially fatal infections.

Even though the Stockert 3T Heater Cooler System is considered very important for the medical community, the increased heart surgery infection risk needs to be considered before the device is used.

This device consists of two temperature controlled water tanks which do not directly contact patients directly. However, the water has the potential to aerosolize and enter the air in the operating room. According to the FDA, the contaminated water can potentially aerorsolize and escape through the device’s exhaust event.

This ultimately allows the M. chimaera bacterium to enter the environment, and contaminate the sterile environment introducing a heart surgery infection risk to the patient. M. chimaera bacterial infections linked with the Stockert 3T Heater Cooler System have been reported in Iowa, Michigan, and Pennsylvania, beginning in 2011.

According to the FDA, at least 12 patients allegedly died due to a heart surgery infection related to heater coolers, and there have been 28 confirmed infections noted by the CDC. It is important to note that patients facing an increased heart surgery infection risk may experience symptoms long after the procedure and should be wary against unusual symptoms including:

• Night sweats
• Muscle aches
• Weight loss
• Fatigue
• Unexplained fever

The FDA first warned against an increased heart surgery infection risk in October 2015, with the agency stating it had received 32 Medical Device Reports (MDR) regarding infections that allegedly developed from cardiac heater cooler devices.

The FDA did not specify the Stockert 3T Heater Cooler System was the device associated with the increased heart surgery infection risk until June 2016. The FDA issued a later warning that year on Oct. 13, 2016 which provided health officials recommendations on how to prevent the M. chimaera bacteria infection from spreading.