On October 13, 2016 a Centers for Disease Control and Prevention (CDC) Health Advisory and Food and Drug Administration (FDA) Safety Communication announced that 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.
Michigan Medicine has been attentively monitoring CDC recommendations since the initial recognition of NTM infections related to heater-cooler devices worldwide. We have identified a small number of patients who have developed this infection among the nearly 7,000 patients at Michigan Medicine who had surgery potentially using the Sorin Stöckert devices.
As recommended by the CDC, we are working to alert any adult or pediatric patients who underwent a surgical procedure with cardiopulmonary bypass (CPB), including cardiac surgery, general thoracic surgery, or vascular surgery from June 2011 to August 2016 about the very small risk of infection with NTM.
We no longer use the Sorin Stöckert 3T heater-cooler devices. We replaced them in August 2016 with different machines not associated with NTM.
See the links below for the latest documents we’ve shared, including the letters sent to patients and referring providers and the latest informational documents like FDA slides and STS update.
Informational Documents
· Information for Clinicians (Updated 12/2016)
· CVC Grand Rounds (Added 12/2016)
· FDA Slides – June 2016 Circulatory Devices Panel Meeting (6/2016)
Notification Letters Sent to Patients and Referring Providers
· Referring Provider Letter (Updated 11/2016)
· Referring Provider FAQs (Updated 11/2016)
Updated 2/2017