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TGA Investigates Heater-Cooler Devices

May 25, 2017

Australia’s Therapeutic Goods Administration is conducting a product safety review of heater-cooler devices after five confirmed reports of Mycobacterium chimaera infections following heart surgery.

All the patient infections in Australia have been associated with Sorin Group’s Stockert 3T heater cooler devices manufactured before September 2014, the TGA said.

The following heater-cooler devices have been withdrawn from the Australian market: Zoll Circulation’s Coolgard; Chalice Medical’s Paratherm; Medos Medizintechnik’s DeltaStream; and Sorin Group’s Stockert Heater-Cooler 3T and Stockert Heater Cooler 1T.

The TGA is also investigating the following heater-cooler devices supplied to the Australian market: Zoll Circulation’s Thermogard XP; Maquet Australia’s HCU 20, 30, 25 and 40 series; and Paragon Healthcare’s Haemotherm CE 400.

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