(b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).The facility owns and operates several heater-cooler systems at the facility, several of which are heater-cooler 1t devices, which are not distributed in the usa.Through a follow-up communication with the customer, (b)(4) learned that the customer does not know which device was used during the patient's procedure(s).The customer reported that all heater-cooler systems are currently in storage and are not in use, with the last unit removed from service in mid-2016.During procedures, the devices are placed inside the operating theatre as far as possible from the patient with the exhaust air directed away from the surgical field.The facility stated that microbiological testing has been performed from 2015 onward, and atypical mycobacterium has been identified in all heater-cooler devices.The samples were reportedly taken from the drain before performing a cleaning cycle.The current cleaning protocols have not been provided by the facility.It is unclear at this time if the reported infection is directly linked to the patient death.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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