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 j323 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j323 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.The customer returned a photograph and the kit with smart card for investigation.A visual inspection of the photograph verifies a tubing leak near the return pump tubing segment.Smart card data confirms that the double needle treatment ended after 971 mls of whole blood had been processed.An examination of the returned kit found a scuff on the return pump tubing segment.Pressure testing confirmed a leak at the site of the scuff.It is unlikely that the tubing segment was damaged prior to product release as an in-process leak test is performed on all kits prior to packaging.The size, shape, and location of the observed damage on the pump loop is consistent with damage that occurs if the pump loop tubing is inadvertently rubbed against the pump head during installation or removal by the end user.The root cause of the tubing leak is most likely the damage to the pump tubing segment that occurred during installation or removal of the pump loop by the end user.No manufacturing related defects were confirmed during the evaluation.No further action is required at this time.This investigation is now complete.Comp (b)(4).S.D.A.20-oct-2020.
|