Plant investigation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device noted that the fiber bundle was wet and revealed the presence blood residue between the polyurethane cut surface and the screw flanges on both ends of the dialyzer.Coagulated blood was observed in the dialysate compartment and on the cavity id end of the dialyzer.During examination, it was noted that there was a fiber at approximately 140º on the cavity id end with the dialysate ports at 0º from which the reported leak may have originated.No other damage or irregularity was noted on the returned sample.The dialyzer was subjected to a laboratory bubble point test.The results did not detect any leak, which was possibly due to the amount of coagulated blood in the blood compartment.Following the test, the dialyzer was subjected to destructive disassembly.Upon removal of the fiber bundle, it was confirmed that there was a fiber from which the reported leak may have originated at approximately 140° with the dialysate ports at 0°, as seen in the earlier visual inspection.No other damage or irregularities were identified.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was one approved temporary deviation notice noted on the lot, which was unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformance, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint.The lot passed all release criteria.The investigation into the cause of the reported problem was able to confirm the failure mode.There was a confirmed defective fiber on the cavity id end of the dialyzer.The complaint has been deemed confirmed.
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