The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane leak.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 g321 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g321 for the reported issue shows no trends.Trends were reviewed for complaint categories, alarm #16: collect pressure and pressure dome membrane leak.No trends were detected for each complaint category.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.Investigation complete.(b)(4).
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