A user facility clinical manager reported that a dialyzer blood leak occurred immediately upon the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak, and it was visually observed.The machine, a fresenius 2008t machine, did not alarm with a blood leak alarm.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient remained on the same machine and treatment was completed successfully with new supplies.The complaint device was confirmed to be available for return, and a return package will be shipped to the clinic to return the dialyzer to the manufacturer for evaluation.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformance's, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Corrective data: added catalog number and serial number of machine.(b)(4).
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