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News From the Food and Drug Administration
December 20, 2016

Heater-Cooler Cautions Updated

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved.

JAMA. 2016;316(23):2474. doi:10.1001/jama.2016.17115

Recent laboratory data have reinforced earlier reports linking certain heater-cooler devices with potentially fatal infections, prompting the FDA to update its safety recommendations.

In question is the Stöckert 3T Heater-Cooler System manufactured by London-based LivaNova PLC, formerly Sorin Group Deutschland GMBH. Such devices are an important tool to help maintain patients’ proper circulating blood temperature during cardiothoracic surgery. However, a 2015 study in Switzerland linked heater-cooler devices used during open-chest surgery with Mycobacterium chimaera infections.

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