Plaintiffs in a cardiac heater-cooler medical device class action lawsuit claim that the units are contaminated with bacteria that cause serious illness or death, and are responsible for several patient deaths related to infections since January 2014.
The Pennsylvania class action suit against the German manufacturer of the Stockert 3T Heater-Cooler System -- LivaNova PLC, formerly Sorin Group Deutschland -- claims that the devices were contaminated with Mycobacterium chimaera. Tests showed the presence of the deadly bacteria in environmental samples from the manufacturing facility in Germany.
Cardiac heater-cooler systems are used during surgery to keep a patient’s blood circulating at the correct temperature. Water is used in the operation of the device, and while it does not come into direct contact with the patient, evaporating water and the system’s exhaust vent may send contaminates into the air. Those airborne particles could infect a patient by entering the chest cavity during surgery.
The U.S. Food and Drug Administration (FDA) issued a safety warning in October 2015 after receiving 32 reports linking serious infections to the Stockert 3T Heater-Cooler System. The FDA issued additional alerts in June 2016 and October 2016, warning patients that they could be at an increased risk for infection during open heart surgery. To date, hospitals in Iowa, Michigan and Pennsylvania have reported infections. A total of 28 cases have been identified in the U.S., and more in Europe.
The suit claims that LivaNova knew or should have known that the Stockert 3T Heater-Cooler System units were infected with the bacteria and exposed patients to “potentially fatal bacteria” during surgery.
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