LivaNova and Maquet Issue an Updated Safety Notice for 3T Systems

December 13, 2016

LivaNova and Maquet published an update to the safety notice for use of 3T systems which are heater-cooler devices used in cardiac surgery, stating a risk of bacterial infection at surgical sites.

Users of these devices must follow additional guidance and notify the manufacturers, LivaNova and Maquet, as well as the medicines and healthcare products regulatory agency, of any contaminated devices.

LivaNova informs users of proper positioning of the device while in the operating room and Maquet has revised instructions for use and disinfection of surgical components.

Companies said that the infection risk is for open-heart surgery patients and is named non-tuberculous mycobacterium. — Cynthia Jessup

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