FDA, CDC issue alerts on Stӧckert 3T Heater-Cooler System

Editor's Note

The Food and Drug Administration (FDA) on October 13 updated its Safety Alert on the Stӧckert 3T Heater-Cooler System by LivaNova to provide new information from the Centers for Disease Control and Prevention (CDC) about Mycobacterium chimaera infections associated with the use of the system in US patients who have had open heart surgery.

The system is used to warm or cool a patient during certain stages of a cardiac procedure.

According to the CDC, the system might have been contaminated during manufacturing, which could put patients at risk for life-threatening infections.

Posted 10/13/2016] AUDIENCE: Risk Manager, Cardiology, Surgery, Infectious Disease, Nursing ISSUE: FDA is updating its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the Stӧckert 3T Heater-Cooler System (3T) in U.S. patients who have undergone cardiothoracic surgeries.