Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The device was properly functional.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Based on the available information, the reported death cannot be traced back to any device malfunction.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Livanova (b)(4) received a medwatch report mw5098936 of a suspected cooling malfunction of heater-cooler system 3t patient circuit during a procedure.Reportedly, the device did not cool the blood as it was supposed to, due to a suspected issue with water flow through the machine.The device was replaced with another.Reportedly, the device was properly working after the procedure.The event outcome reported within the medwatch report mw5098936 is death.No relationship between device malfunction and patient death was stated within the provided report.
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