FDA: Possible link between Mycobacterium chimaera infections and Stockert 3T Heater-Cooler System

Editor's Note

The Food and Drug Administration (FDA) on June 1 issued a safety alert that the agency had received reports of US patients infected with Mycobacterium chimaera after undergoing cardiothoracic surgery that involved the use of the Stockert 3T Heater-Cooler System by Sorin Group Deustchland GmbH.

Efforts are underway to determine if M chimaera infections in US patients are the same as those previously identified in European patients.

A recently published European study suggests a direct link between the M chimaera found in infected cardiothoracic patients and environmental samples of M chimaera found in the device manufacturer’s production and servicing facility in Germany.

Posted 06/01/2016] AUDIENCE: Risk Manager, Cardiology, Surgery, Infectious Disease, Nursing ISSUE: The FDA has received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T. Currently, efforts are underway in the U.S. to determine if the infections in U.S. patients and M.