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 h373 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot h373 shows no trends.Trends were reviewed for complaint category, pressure dome membrane leak.No trends were detected for this complaint category.Of the cellex operator's manual (1460415 rev 5.0) on warnings and cautions states "you must be present to supervise the treatment at all times.Your primary responsibility during collect, photoactivate, and reinfuse is the patient's safety.Carefully monitor the patient for tolerance to the extracorporeal fluid shifts, access performance and potential allergic reactions." 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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