FDA Safety Communication for 3T Heater-Cooler System

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FDA Safety Communication for 3T Heater-Cooler System

Today the FDA issued a Safety Communication on “Mycobacterium chimaera Infections Associated with Sorin Group Deustchland GmbH Stӧckert 3T Heater-Cooler System.” In this safety communication, the FDA is providing new information and recommendations specific to Mycobacterium chimaera (M. chimaera) infections associated with the use of the Stӧckert 3T Heater-Cooler System in patients who have undergone cardiothoracic surgeries.

In testing conducted by the manufacturer in August 2014, M. chimaera contamination was found on the production line and water supply at the facility in Germany where the Stӧckert 3T Heater-Cooler System is manufactured. The units that were manufactured at this facility were distributed worldwide. In response to the M. chimaera findings in August 2014, the manufacturer added cleaning and disinfection procedures to the production line in September 2014. Samples taken at the same manufacturing facility in June 2015 did not show M. chimaera on the production line, potentially eliminating the production line as a contamination source.

The FDA has received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery when the Stӧckert 3T Heater-Cooler System was used during their surgery. The FDA’s recommendations to health care facilities staff and health care providers that purchased and used this device prior to September 2014 are based on currently available findings. During the June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting, the FDA will review available data and seek expert scientific and clinical opinion related to all heater-cooler device contaminations, associated patient infections, and mitigation strategies. As new and important information becomes available, the FDA will evaluate the information and update its recommendations, as appropriate.

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