Cardiac heater-cooler infection has become a serious concern throughout the patient population and medical community, as numerous patients may be at risk for a potentially fatal bacterial infection.

The cardiac heater-cooler infection concern stems from the Sorin 3T Heater-Cooler System, which is often utilized during open heart surgeries and other procedures.

The FDA first warned the public against potential cardiac heater-cooler infection in October 2015, with the agency stating it had received 32 Medical Device Reports (MDR) indicating this troubling correlation.

While the FDA at first did not specify which cardiac heater-cooler was suspected of causing these infections, a later warning in June 2016 named the Sorin 3T Heater-Cooler System by LivaNova PLC.

These infections are being caused by M. chimaera bacteria, which is often found in soil and water and can be potentially fatal in rare cases. LivaNova PLC had discovered the contamination of their devices in September 2014, during regular testing in their manufacturing plant in Germany. The contamination was reportedly resolved in July 2015, when the manufacturing plant was tested again.

These cardiac heater-cooler infection cases can potentially develop months or even years after a surgery, so potentially affected patients are advised to be highly vigilant against any unusual or aggressive symptoms including:

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

Cardiac heater-cooler infection cases have already been reported in Iowa, Michigan, and Pennsylvania from 2011 to present; the CDC stated there have been a total of 28 confirmed cardiac heater-cooler infection cases. The FDA reported that at least 12 patients have died from this infection, and that the bacteria can fester long after the surgery.

Overview of Cardiac Heater-Cooler Infection

The Sorin 3T Heater-Cooler System is a temperature control device utilized to keep patients’ body temperature under control during surgery.

The device consists of two temperature controlled water tanks. While the water and tanks do not make direct contact with the patient, the FDA states “there is potential for contaminated water to enter other parts of the device and aerosolize.” This means that M. chimaera bacterial cells can escape “through the device’s exhaust vent” and onto or into the patient.

Cardiac heater-cooler systems are used in approximately 250,000 open heart surgeries a year, with a significant portion of the devices linked to potentially deadly heater-cooler infection. The FDA says these bacterial infections are rare, but affected patients may not be aware they have been contaminated until months or years later.

The most recent warning regarding cardiac heater-cooler infection was released on Oct. 13, 2016, and provided healthcare facilities with instructions to help prevent the infection from spreading. The FDA stated no cardiac heater-cooler infections have been reported with 3T medical devices manufactured after September 2014.

Even though LivaNova had taken steps to help minimize the risk of cardiac heater-cooler infection, the company is still facing major product liability claims. There have been several lawsuits filed against the company by patients alleging the company either knew or should have known about the risk of cardiac heater-cooler infection and warned the public much earlier.