CDC Advisory

CDC links patient infections to potentially contaminated heater-cooler device

The Centers for Disease Control and Prevention (CDC) has informed McLaren Health Care that Stӧckert 3T Heater-Cooler devices manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) may have been contaminated with Mycobacterium chimaera (M. Chimaera) in the manufacturing process, and that patients for whom these devices were used during cardiac surgery may be at risk of developing infections.

The CDC has determined that these devices were contaminated with NTM during the manufacturing process and prior to being delivered to hospitals. These devices are used by thousands of hospitals both in the United States and worldwide.

Patient safety is top priority at McLaren Health Care, so we are working to notify previous open-chest cardiac surgery patients who may be affected. Although the possibility of transmission is low, even one infection is too many. That is why we are taking proactive action to notify patients and their physicians.

Of the more than 2,100 patients who have had open heart surgery at a McLaren Health Care hospital, we are not aware of any who have developed this infection. While not required by the CDC, McLaren has elected to remove all these devices from service and replace them with new units.

We have provided educational materials from the CDC to our clinical staff and physicians about how to identify the signs of an infection in post-surgical patients. As a standard practice, we will continue to monitor reports from the CDC and the FDA detailing concerns.

If you are experiencing the following symptoms, please contact your primary care provider immediately:

  • night sweats
  • muscle aches
  • weight loss
  • fatigue
  • unexplained fever

Additional Information

Need More Help?

If you have additional questions, please click one of the links below to select a contact form for the hospital where your surgery was performed. We’ll have one of our health care professionals contact you.