A user facility reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the dialyzer.Blood test strips were unavailable at the time of the event.It was confirmed that the machine, a fresenius 2008 k2, alarmed appropriately with a blood leak alert.Medi-system bloodlines were used for the treatment.No damage was identified on the dialyzer.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was reported to be 300 ml.Follow-up with the clinic¿s registered nurse confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.The dialyzer was not available to be returned for evaluation as it was reportedly discarded.Patient information was requested, however, it was not documented in the clinic's incident report.
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Patient code replaced (transcription error) plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, non-conformances, deviation, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
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