Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.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-conformances, 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 not able to be confirmed.A review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
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A user facility nurse reported that an internal dialyzer blood leak occurred approximately three hours after the initiation of a patient¿s hemodialysis (hd) treatment.The machine (fresenius 2008t) alarmed for minor blood leak and blood was noted on the arterial side and top of the dialyzer to the red hansen connector.Blood test strips were used but the results were negative for the presence of blood.It was reported that there was a defect in the fiber membrane of the dialyzer, but no further description of the damage was provided.The patient¿s estimated blood loss (ebl) was noted as being approximately 200cc as the patient¿s blood was only returned on the arterial side.No patient adverse effects were experienced, and no medical intervention was required because of this event.The patient completed treatment with a new set-up of supplies on a different machine without any complications.The complaint device was not available to be returned to the manufacturer for evaluation.
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