3T Heater-Cooler System manufacturer LivaNova issued a medical device correction letter on October 18, indicating that the blood temperature regulating machines would be redesigned and new cleaning instructions would be issued to hospitals to reduce the risk of infections among patients. The manufacturer also provided the customers with an updated set of instructions regarding the monitoring and use of hydrogen peroxide in the 3T Heater Coolers.
The U.S Food and Drug Administration (FDA) issued a safety communication last week about the information actively supporting the manufacturer. The FDA stated that the U.S. Centers for Disease Control and Prevention (CDC) is actively evaluating LivaNova’s infection mitigation efforts and are doing their own scientific research to issue appropriate updates soon. Sorin 3T Heater-Coolers are used during heart bypass surgeries, valve replacement surgeries, and other cardiac surgeries to regulate a patient’s blood temperature. But in recent years, reports suggested that certain devices manufactured before September 2014 might be contaminated with bacteria. Lawsuits filed against the company claim that the contamination caused Mycobacterium chimaera or Mycobacterium abscessus infections in patients with compromised immune systems and an open chest cavity during heart surgery.
There are nearly 135 lawsuits filed against the Sorin Group with allegations that their Stockert 3T Heater-Cooler device spreads a bacteria called nontuberculous mycobacteria (NTM). The U.S. JPML consolidated similar lawsuits in February 2018 into a single multidistrict litigation (MDL No. 2816) in the Middle District of Pennsylvania before Judge John E. Jones III for coordinated pretrial proceedings.
