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 l319 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l319 shows no trends.Trends were reviewed for complaint categories, alarm #17: return pressure and clot observed.No trends were detected for these complaint categories.A video was provided by the customer for evaluation.The complaint kit was not returned.Review of the provided video verifies the reported blood clotting in the centrifuge bowl.In addition, an alarm #17: return pressure alarm is seen on the cellex display at the photoactivate stage of the treatment.There appears to be blood solids and clotting in the treatment bag.Section 2-9 of the cellex operators manual (1470493 rev 6) for use with software 5.4 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 physician 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 root cause for the alarm #17: return pressure alarm was most likely due to the clotting in the kit.The root cause for the clotting observed could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).N.S.(b)(6) 2022.
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