The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction clot observed in the return line.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot k109 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k109 shows no trends.Trends were reviewed for complaint categories, clot observed and alarm #17: return pressure.No trends were detected for these complaint categories.Photographs were provided by the customer for evaluation.The complaint kit and smart card were not returned.Evaluation of the provided photographs verify the reported clotting in the return bag and blood filter.An additional photograph shows several syringes with blood clots coming out of the luer end.The reported clotting in the return line could not be verified based on the photographs provided.The cellex operators manual section on anticoagulant states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The clinician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgement to establish the optimal heparin dosage for each patient." the cause of the reported alarm #17: return pressure was most likely due to the clotting in the kit.The root cause for the blood clotting could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).
|