Heater-Cooler Device Information for Healthcare Providers

The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) recently informed all U.S. hospitals that there is a less than 1 percent chance that patients who had open-heart surgery may develop a rare bacterial infection related to a specific device used during the procedure.

According to the CDC, the exhaust air from a machine used throughout the United States during certain open-heart surgeries may have contained a type of slow-growing bacteria (Mycobacterium chimaera, a type of nontuberculous mycobacteria, NTM) as a result of contamination during manufacture of the device. The specific machine is the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T Heater-Cooler System.

CDC is recommending that clinicians, including cardiologists and general practitioners who take care of cardiac surgery patients before and after their surgery, be aware of the risk and consider NTM as a potential cause of unexplained chronic illness. M. chimaera are slow-growing bacteria and infections may take months or even years to cause symptoms.

Patients with NTM infections following cardiac surgery have presented with a variety of diagnoses. Common examples include endocarditis, surgical site infection, or abscess and bacteremia. Other clinical manifestations have included hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis.

There is no test to determine whether a person has been exposed to NTM bacteria. When seeing patients with possible NTM infections and a history of cardiac surgery, clinicians should consider arranging consultation with an infectious disease specialist. If an NTM infection is suspected, it is important to obtain acid fast bacilli (AFB) cultures from an infected wound and/or blood. M. chimaera may be identified as part of the Mycobacterium avium complex.

Physicians who identify a patient with M. chimaera infection following cardiac surgery performed at Cedars-Sinai should notify Hospital Epidemiology at 310-423-5574.

There also is extensive information available through the CDC.