Plant investigation: the customer reported the failure with "medical event" for one filter of hf80s/ batch b2bc16100 during treatment.The following investigation tasks have been performed: a review of instruction for use (ifu) and/or label evaluation if product deficiency relates to falsification investigation/testing of returned, retained and/or reference samples, review of batch documentation, review complaint history and trending review of relevant capas.The described situation is adequately addressed in the ifu and/or on the label and the product deficiency is not related to falsification.The complaint sample was not available and no meaningful pictures were attached so further analysis could not be performed.Due to 100% testing, it is highly unlikely to detect a failure in the retention sample.Furthermore, only a small number of reserve samples are available.Therefore the retention sample analysis was not performed.Batch record investigation was performed.25.608 products have been inspected according to the inspection protocol and were found conforming to specifications and have been released without any discrepancies.No indication for any relationship with the reported failure mode has been found during the review.Complaint history review for affected product and product family was performed.One further complaint regarding the batch was received.The described situation is covered in the risk analysis.
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It was reported that a hemodialysis machine gave an alarm and high tmp was observed a few minutes after the initiation of hemodialysis treatment.The nurse immediately found that there was coagulation in the dialyzer product number hf80s batch b2bc16100.When priming the bloodline with normal saline, the dialyzer with 3-degree agglutination was found, and the dialyzer and bloodline were replaced.After the replacement of the dialyzer, the dialysis treatment was completed successfully.No harm occurred to the patient.The complaint sample was not available for return to the manufacturer for physical evaluation.The estimated blood loss (ebl) volume is unknown.No additional information could be obtained.
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