The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 g346 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot g346 for the reported issue shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #18: system pressure.No trends were detected for each complaint category.Photographs were returned for evaluation.A review of the customer provided photographs confirm the tubing leak as blood is seen in the pump head location and pump tubing loop.The damage to the tubing is consistent with damage caused by improper installation of the pump loop tubing into the pump head.During installation of the kit by the end user if the pump loop is forcefully rubbed against the pump head it can result in scraping and potentially cutting the tubing loop as the pump head rotates.A material trace of the tubing used to manufacture lot g346 found no related non-conformances.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 the tubing damage was present at the time of manufacture.The investigation determined the root cause of the tubing leak was most likely improper installation of the pump loop by the end user.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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