Patient identifier and weight not provided.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 (b)(4).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow-up communication with the customer livanova learned that the unit was placed inside operation room and were briefly quarantined, but they have started to use them again when they figured out how to place them outside.Further it was reported that the device was cleaned according the instruction for use (ifu).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Corrective actions are in progress for the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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