FDA Investigating Reports of M. Chimaera Infections Following Use of 3T Heater-Cooler System

WASHINGTON, D.C. — The Food and Drug Administration says it has received reports of patients in the United States infected with M. chimaera following cardiothoracic surgery that involved the use of Sorin Group’s Stockert 3T Heater-Cooler System.

A June 1 FDA Safety Communication states that “efforts are underway in the U.S. to determine whether the infections in U.S. patients and M. chimaera isolates from samples taken from the 3T are linked with M. chimaera isolates from European patients were were infected and the M. chimaera previously identified at the 3T manufacturer’s production and servicing facility in Germany.”

The FDA said …