The heater-cooler device 16-02-80 is not distributed in the usa.However, it is similar to the heater-cooler device 16-02-85, which is distributed in the usa (510(k) number: k052601).(b)(4) implemented a field safety notice for disinfection and cleaning of (b)(4) heater-cooler devices.The z number is z-2076/2081-2015.(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 reporting facility ((b)(6) hospital) has reported that multiple heater-cooler devices have been found to be contaminated with mycobacterium chimaera (see medwatch reports 9611109-2017-00114, 9611109-2017-00115 and 9611109-2017-00116 for details on the units).The facility does not track which unit is used for a given procedure, so it is unknown which of these devices was used during the patient's procedure.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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