A hospital technologist reported that an internal dialyzer blood leak occurred immediately after the initiation of a patient¿s hemodialysis (hd) treatment.The machine alarmed for blood leak and a small leak was visually confirmed from a strand of fiber inside the dialyzer.Blood test strips were used and confirmed the presence of blood.Treatment was interrupted as the patient¿s blood was returned and the dialyzer was replaced, then, treatment was resumed.There was no reported amount of blood loss.No patient adverse effects or injury and no medical intervention were reported in response to this event.The complaint device was not stated to be available to be returned to the manufacturer for physical evaluation.
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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 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-conformance, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint.The lot passed all release criteria.The complainant provided a photograph of the event, which appeared to depict blood in the dialysate compartment of the dialyzer.This may or may not indicative of an internal blood leak.Although a photograph was provided, a definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is unconfirmed.
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