There was no patient involvement.This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.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 service representative was able to confirm the reported issue and traced it back to the compressor.The unit was recommended to be returned to livanova (b)(4) for further investigation and repair.During investigation a hole inside the evaporator was identified as root cause of the reported failure.After device assessment, a repair was not recommended and the device scrapped.A replacement unit was provided to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Corrective actions are in progress for this issue.
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