The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pto leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot g316 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g316 for the reported issue shows no trends.Trends were reviewed for complaint categories, pto leak, alarm #1: air detected and alarm #9: blood pump error.No trends were detected for each complaint category.Photographs were returned for evaluation.The smartcard was not returned; therefore, no confirmation of the reported alarms could be made.The customer provided photographs show the pump tubing organizer (pto) installed in the pump deck with blood leaking around the filter area within the pto.The leak is confirmed based on the photographs provided; however, the source of the leak could not be determined based on the available information.A device history record review did not identify any related non-conformances, and this kit lot had passed all lot release testing.Cellex kits are 100% leak tested prior to packaging.A leak of this nature would have been detected during in-process testing; therefore, it is unlikely a leak in the pto area was present at the time of manufacture.No manufacturing related defects were identified through this investigation.No further action is required at this time.This investigation is now complete.(b)(4).
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