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 j254 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot j254 shows no trends.Trends were reviewed for complaint categories, alarm #17: return pressure, clot observed and bags/lines swapped.No trends were detected for these complaint categories.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Section 2-9 of the cellex operators manual (1470096 rev c) for use with software 5.1 on placement of saline and anticoagulant bags states "caution: the correct placement of the saline and anticoagulant bags is essential.Incorrect placement may lead to clotting in the procedural kit, patient blood loss, and a failed treatment." the customer reported the anticoagulant and saline bags were incorrectly placed while installing the kit.The cause of the alarm #17: return pressure alarm was most likely due to the clotting in the return line.The root cause of the clots observed was most likely due to the operator inadvertently swapping the anticoagulant and saline bags during kit installation.No further action is required at this time.This investigation is now complete.(b)(4).P.T.15-apr-2021.
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