Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow-up communication livanova learned that the device was cleaned as per the instruction for use and placed inside the operating theatre during use with the fan directed opposite to the patient at an estimated distance of 3.5 meters from the surgery field.However, the serial number of the device used during surgery remains unknown.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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