A Texas man has filed suit against three medical device manufacturers, alleging that their Sorin 3T heater-cooler system used during his wife’s cardiac surgery was contaminated and ultimately led to her death.
According to the suit, Stephanie H. underwent open-heart surgery in February 2015. During that surgery, her temperature was controlled by a Sorin 3T heater-cooler system. In March 2016, Stephanie was hospitalized with complaints of weakness, shortness of breath and bilateral leg pain. She was diagnosed with “severe metabolic acidosis and rhabdomyolysis,” and died of septic shock on March 9, 2016.
The Sorin 3T heater-cooler helps maintain a surgery patient’s optimum body temperature by circulating temperature-controlled water through the body. It was originally manufactured by Sorin Group Deutschland GmbH and Sorin Group USA, which merged with LivaNova PLC in 2015. All three manufacturers are named in the lawsuit.
According to the U.S. Food and Drug Administration (FDA), testing conducted in August 2014 in the manufacturer’s production facility revealed contamination with Mycobacterium chimaera. This type of infection may not manifest in a patient until months or even years after surgery. Symptoms include fatigue, breathing difficulty, fever and night sweats.
The FDA says it has received reports in the U.S. of patients infected with M. chimaera after having surgery that involved a Sorin 3T heater-cooler device. In addition, a European study linked infections in European patients with contamination in the Sorin 3T device.
The lawsuit, filed in the U.S. District Court for the Western District of Texas, seeks damages in an unspecified amount for defective manufacture and negligence.
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