There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Through follow-up communication livanova learned that the error code occurred after a couple of hours of being on bypass and the user did not know which error code was actually displayed.He turned the unit off and on again and the heating process was slower.The unit was replaced with a another to complete the procedure.A livanova field service representative was dispatched to the facility to investigate the device and he could not reproduce any error code.The unit was found to be working according to the specifications.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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