Numerous open-heart surgery patients allege they developed a surgical wound infection after the Stockert 3T Heater Cooler System was used during their surgery.

The surgical wound infection instances reportedly stem from a bacterial strain called mycobacterium chimaera (M. chimaera), which can be potentially fatal for patients. This bacteria is often found in water or soil and is rarely dangerous to humans, but it can become problematic if the cells come into contact with open wounds.

The Stockert 3T Heater Cooler System consists of two temperature controlled water tanks, which do not make direct contact with the patient. However it has been noted that these M. chimaera bacteria can potentially colonize other parts of the machine and become aerosolized, which means that the bacterial cells can enter the air and make direct contact with the patient’s surgical area.

The M. chimaera bacteria was reportedly discovered in a facility in September 2014, which was a manufacturing plant for the Stockert 3T Heater Cooler System.

While the FDA states that the M. chimaera infection is rare, patients can develop a surgical wound infection months or even years after the procedure due to how long the infection can take to develop. Patients who develop this potentially fatal surgical wound infection, should be wary of any serious complications including:

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

According to the CDC, there have been a total of 28 confirmed surgical wound infection incidents with the FDA further stating that at least 12 patients have died.

This surgical wound infection has been linked to patients who had the Stockert 3T Cardiac Heater Cooler used during their surgeries in Iowa, Michigan, and Pennsylvania beginning in 2011.

Overview of Cardiac Heater Cooler Infections

The Stockert 3T Health Cooler System is a heating and cooling device, which is used to help control a patient’s body temperature during surgery.

This device is considered very important in the medical world, as it maintains a healthy temperature for organs and blood. Cardiac heater coolers are used in approximately 250,000 open heart surgeries every year, with approximately 60% of the devices allegedly linked to potentially deadly surgical wound infection.

The alleged association between Stockert 3T Heater Coolers and surgical wound infection instances was publicized in October 2015, when the FDA issued its first safety communication. The agency had reportedly received 32 Medical Device Reports (MDR) describing potentially fatal surgical wound infection instances in patients who had undergone surgery using heater cooler device.

However, the FDA did not specify the Stockert 3T Heater Cooler System until a later warning in June 2016. The most recent warning from the FDA was released on Oct. 13, 2016, which provided health officials with recommendations on how to prevent the spread of the surgical wound infection.

The contamination at the manufacturing facility was reportedly resolved in July 2015 when the facilities were retested, with the FDA stating that Stockert 3T Heater Cooler System device manufactured after September 2014 should be free from the risk of contamination.