On October 13, 2016 a Centers for Disease Control (CDC) Health Advisory and Food & Drug Administration (FDA) Safety Communication announced that the Stöckert 3T heater/cooler devices by LivaNova PLC (formerly the Sorin Group) may have been contaminated with Mycobacterium chimaera (M.Chimaera), a rare type of nontuberculous mycobacterium (NTM), during manufacturing.
Tri-City Medical Center has been monitoring CDC recommendations since the initial recognition of infections world-wide.
- At this time, we are investigating whether any patients have developed this infection among the patients at Tri-City Medical Center who had surgery potentially using the Sorin Stöckert devices.
- As recommended by the CDC, we are working to alert any patients who underwent a surgical procedure with cardiopulmonary bypass (CPB), including cardiac surgery, general thoracic surgery, vascular or general surgery from February 2010 to present about the very small risk of infection with nontuberculous mycobacterium, or NTM.
- We are in the process of replacing the Sorin Stöckert 3T heater-cooler devices. New machines have been ordered that have no history of association with NTM.
- If you believe you had a procedure (utilizing cardiopulmonary bypass machine or heart-lung machine) with either a cardiac surgery, general thoracic surgery, vascular or general surgery procedure from February 2010 to present, and have symptoms including night sweats, muscle aches, weight loss, unexplained fever or drainage or redness of surgical wound, please contact your primary care provider.
- The CDC website (link is external) has more information, including FAQs.
