The occurrence of deadly heart surgery infection has become a serious concern to the medical community and patient population after numerous warnings indicated serious safety problems with certain cardiac heater cooler devices.

Used in hundreds of thousands of surgeries per year, cardiac heater coolers can stabilize patients’ body temperature.

The cardiac heater cooler device recently associated with deadly heart surgery infection is the Sorin 3T Heater Cooler System by LivaNova PLC, with models manufactured in a certain plant in Germany before September 2014. According to the FDA and CDC, contamination with nontuberculous mycobacteria was discovered when the facility was tested in Sept. 2014.

The cardiac heater cooler devices reportedly were contaminated with Mycobacterium chimaera (M. chimaera), which is typically found in water and soil. This non-tuberculous bacteria can be potentially deadly to patients, potentially inducing deadly heart surgery infection.

There have already been several reports of serious injury and death, reported in Iowa, Michigan, and Pennsylvania stemming back to 2011. According to the CDC and FDA, there have been 28 confirmed cases of deadly heart surgery infection and at least 12 patient deaths, respectively.

Healthcare facilities are highly cautioned against using Sorin 3T cardiac heater coolers manufactured before September 2014, and to take precautions against the potential spread of infection. While the FDA states deadly heart surgery infection from this bacteria is rare, it could take months to years before symptoms start showing.

Patients who recently underwent heart surgery using this Sorin 3T Heater Cooler System should be vigilant against any of the following symptoms:

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

Overview of Deadly Heart Surgery Infection

The Soring 3T Heater Cooler System consists of two tanks filled with temperature controlled water, which are used to stabilize the patient’s body temperature while under anesthetic. While the water in the tanks does not touch the patient, the liquid in the containers could potentially aerosolize.

According to the FDA, bacteria from the contaminated water can be become airborne through the process of aerosolization and escaping through the device’s exhaust vent. This allows the M. chimaera bacteria to escape into the surrounding environment, and make direct contact with the patient.

The FDA first warned against potentially deadly heart surgery infection in October 2015, stating that it had received 32 Medical Device Reports (MDRs) indicating a potential correlation to cardiac heater cooler devices.

During this time, the FDA did not specify the Sorin 3T device and had told the public it would “monitor the situation.” The FDA later confirmed the Sorin 3T Heater Cooler to be linked to the M. chimaera infection reports in June 2016, and had sent out another warning the same year with recommendations on how to prevent the spread of infection.

The contamination of the Sorin 3T Heater Cooler was reportedly resolved in July 2015, when the facility was retested. The FDA states there should be no risk of deadly heart surgery infection in devices manufactured after September 2014.