Media Contact: Haley Otman 734 764-2220

Heater-cooler devices and NTM infections

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 have alerted 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 alternative devices.

See the links below for additional information.

Informational Documents

Information for Clinicians (Updated 11/2018)

CDC toolkit (Added 11/2016)

FDA update (Added 11/2018)

Notification Letters Sent to Referring Providers

Referring Provider Letter (Updated 11/2016)

 

Updated 11/2018

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