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 g350 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g350 shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.A photograph was provided by the customer for evaluation.The photograph shows evidence of a blood leak within the pump tubing organizer (pto).The exact location of the leak within the pto cannot be identified in the customer photograph; however, it appears that the source of the leak could be from the pto filter weld or the tubing bonds inside the filter sockets.The pto filter weld and tubing bonds inside the filter sockets are 100% leak tested as a subassembly and again during finished product testing.A review of the manufacturing history log found no unscheduled maintenance associated with the pto filter welder during the manufacture of kit lot g350.A device history record review for kit lot g350 did not identify any related non-conformances, and this kit lot had passed all lot release testing.The root cause of the pto leak could not be determined based on the available information.No further action is required at this time.Investigation complete.(b)(4).
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