LivaNova PLC is facing a new product liability claim recently filed by a New York couple who allege that a contaminated heater-cooler device was used during the husband’s open heart surgery.

This allegedly contaminated heater-cooler device used during the claimant’s opened heart surgery was manufactured and provided by LivaNova PLC. The couple claims it caused him to develop a deadly infection.

Plaintiff couple Donald H. and Agnes H. jointly filed this cardiac heater cooler lawsuit, alleging the contaminated heater-cooler device had caused Donald to develop a potentially fatal surgical infection.

The contaminated heater-cooler device in question is the Sorin 3T Heater Cooler device, which is used to help manage the patient’s body temperature during surgery.

The Stockert 3T Heater Cooler device consists of two temperature controlled water tanks. Even though water does not directly make contact with the patient, the water can escape through the device’s exhaust vent when it becomes aerosolized. This also allows bacterial contaminants to escape and make direct contact with patients.

The Stockert 3T Heater Cooler and other heater-cooler devices are used throughout the country in hospitals in approximately 250,000 open heart surgeries every year. These cardiac heater cooler devices are considered very important to the medical community and are used to keep the temperature of internal organs under control during bypass surgeries.

With these benefits in mind, the couple claims, the Stockert 3T Heater Cooler device was used during Donald’s open heart surgery on Jan. 2, 2015. At some point after the surgery, Donald had developed a deadly infection and has had to contend with the condition ever since.

According to the cardiac heater cooler lawsuit, Donald had to be hospitalized and undergo several invasive medical procedures to treat the infection which was allegedly caused by the contaminated heater-cooler device.

Overview of Contaminated Heater-Cooler Device Allegations

Certain models of the Sorin 3T Heater Cooler device were reportedly contaminated with rare non-tuberculosis bacteria called Mycobacterium chimaera (M. chimaera), which is typically found in water or soil. This bacteria can be deadly if it makes contact with humans, especially in open surgical wounds.

According to the FDA and CDC, models of the Sorin 3T Heater Cooler devices manufactured before September 2014 may have been contaminated with the M. chimaera bacterium. The contamination was reportedly discovered in September 2014, while the facility was undergoing testing.

This problem was reportedly resolved in July 2015 when the facility was tested again, with the FDA stating that Sorin 3T Heater Cooler devices manufactured after September 2014 were not at risk for contamination.

The FDA issued a public safety warning regarding these problems in October 2015, but the agency did not specify that the contaminated heater-cooler device was not the Sorin 3T Heater Cooler device until a later warning in June 2016.

At least 12 patients have reportedly died from these cardiac heater cooler infections, with the CDC reporting a total of 28 confirmed infections. The FDA further stated that these infections can develop months or even years after the surgery, so patients should be aware of the following symptoms:

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

Donald and Agnes allege his infection was caused by the contaminated heater-cooler device and claim the manufacturing company failed to warn the general public.

This Contaminated Heater-Cooler Device Lawsuit is Case No. 1:18-cv-00744-GLS-DJS in the U.S. District Court for the Northern District of New York.