The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.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 h168 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h168 shows no trends.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: blood leak? (centrifuge chamber).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.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).S.D.A.07-aug-2020.
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