Numerous patients who have undergone open heart surgery using the Stockert 3T heater cooler device have reportedly developed a deadly Mycobacteria chimaera infection.

The Myobacteria chimaera infection, which develops from a non-tuberculous mycobacterium (NTM), is a rare but life-threatening bacterial infection that can be caused by contaminated components in the Stockert 3T heater cooler device.

These heater cooler devices are commonly used during cardiac surgeries to help maintain an ideal body temperature for the patients. While these devices are used on 250,000 open heart surgeries per year, approximately 60% of these devices are linked to to the potentially fatal Mycobacteria chimaera infection.

The Mycobacteria chimaera bacterium is typically found in soil or water. When it invades a person’s body under delicate circumstances like open heart surgery, it can be potentially fatal as NTM infections typically do not respond to antibiotics. This makes the Mycobacteria chimaera infection risk especially dangerous in patients who have compromised immune systems or patients who have undergone a cardiopulmonary procedure.

The cardiac heater cooler device consists of two water tanks that help regulate the temperature of cardiac patients during surgery. Water does not have direct contact with patients at all. The Mycobacteria chimaera infection risk stems from water that becomes aerosolized during surgery and expelled through the device’s exhaust system.

Once the bacteria becomes airborne, it can potentially come into contact with patients. It is important to note that Mycobacteria chimaera infection symptoms may not appear immediately after surgery, but can take weeks or months to develop.

Due to the severity of the Mycobacteria chimaera infection, it is important for patients to be vigilant against NTM side effects including:

• Night sweats
• Aching muscles
• Joint pain
• Weight loss
• Fatigue
• Fever

While the Mycobacteria chimaera infection is not contagious, it is an aggressive infection that needs to be treated as quickly as possible. Even though NTM infections are rare, the FDA states the Mycobacteria chimaera infection may have resulted in the death of up to 12 patients who used the Stockert 3T heater cooler device.

FDA, CDC Warn about Infection from Open Heart Surgery

Both the FDA and CDC have warned that a number of Stocker 3T heater cooler devices may have been contaminated at some point during the manufacturing process in Germany. The contamination was discovered in September 2014. The company claimed the risk was resolved in July 2015.

The FDA and CDC have been warning the public about this bacterial infection since October 2015, stating that these devices could potentially allow for Mycobacteria chimaera to come into contact with patients.

The FDA issued the first public safety warning regarding the devices in October 2015. The agency reported it had received 32 adverse event reports regarding the Stockert 3T heater cooler devices. The FDA sent out a later warning in June 2016 stating that the cardiac heater cooler devices could be linked to Mycobacteria chimaera infection.

Even though these public warnings help prevent future cases of Mycobacteria chimaera infection, this does not help patients who have already experienced this. Patients who suffered Mycobacteria chimaera infection possibly due to the Sorin 3T heater cooler device may be eligible for legal action.