A user facility registered nurse (rn) reported that a dialyzer blood leak occurred upon the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was confirmed to be internal, as it was visually observed within the hanson lines.It was reported that there was no harm to the patient.Additional information was requested, however to date a response has not been received.There was no patient injury, adverse events, or medical intervention initially reported.The complaint device was not returned to the manufacturer for 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.The production record review showed there was one approved temporary deviation notice (dn) in the production of this lot.It is unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.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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