There was no patient involvement.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 confirm the reported issue.The failure was traced back to a defective level sensor indicating an empty tank when the tank was full of water and this led the user to overfill the device.Water entered pump circuit boards which got damaged leading to the reported smoke.Thus, the patient bridge and cardioplegia bridge as well as distributor and ac mains board were replaced.The problem could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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