FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

TGA Issues Update on Infections Linked to Heater-Cooler Devices

Feb. 12, 2019
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Australia’s Therapeutic Goods Administration issued an alert to say that nine Australians have been confirmed with Mycobacterium chimaera infections following heart surgery involving heater-cooler devices.

The confirmed cases of infection were associated with contaminated Stöckert Heater-Cooler 3T heater-cooler units that were manufactured before September 2014, the agency said.

The heater-cooler devices, used in operating theatres and intensive care units to control the temperature of blood, contain water tanks that provide temperature-controlled water. The TGA previously reported evidence to suggest that patients are infected when bacteria in the device's water tank becomes airborne in the operating room during surgery.

LivaNova, the sponsor of the Stöckert 3T devices in Australia, has taken steps to modify the 3T units to prevent aerosol dispersion.

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