A user facility clinical manager reported that a dialyzer blood leak occurred 3 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 300ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
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Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the gross visual examination of the sample, a delamination was observed on the non-cavity id end which extended from approximately 305° to 70° with the dialysate ports at 0°.There were no defects or irregularities visually identified on the fiber bundle or any of the molded dialyzer components.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were two approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The investigation into the cause of the complaint was able to confirm the reported event.
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