The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the 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 of kit lot f111 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f111 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak and alarm #17: return pressure.No trends were detected for these complaint categories.The assessment is based on information available at the time of the 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.
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The customer called to report a pressure dome membrane leak that occurred during a treatment procedure.The customer stated that they had a few alarm #17: return pressure alarms prior to the leak, but there was no alarm at the time of the leak.The customer reported that the leak occurred after 270ml of whole blood processed.The customer stated that the leak went onto and around multiple components on the instrument's pump deck.The customer reported that the outer edge of the system pressure dome's membrane was partial dislodged from the body of the system pressure dome.The customer stated that there was no tear, rip, or puncture in the pressure dome's membrane.The customer reported that the treatment was aborted with no blood/products returned to the patient.The customer stated that the patient was in stable condition before, during, and after the issue, and no medical intervention was required.The customer reported that a saline bolus was administered to the patient.The customer confirmed that the patient was not impacted by the incident.The kit was not returned for investigation.
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