The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome 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 k164 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k164 shows no trends.Trends were reviewed for complaint categories, pressure dome leak and alarm #18: system pressure.No trends were detected for these complaint categories.The product monitoring data is within control limits.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.The customer reported they slightly touched the system pressure dome during the treatment, and the pressure dome detached from the pressure sensor and leaked.Section 9-5 of the cellex operators manual (1470493 rev 06) for use with software 5.4 states "warnings and cautions: do not remove any pressure dome during a treatment".In addition, section 6-25 alarm #18 system pressure correction action states "do not remove the system pressure dome." the root cause of the reported pressure dome leak was most likely due to the operator inadvertently touching the system pressure dome causing it to detach from its sensor.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.No further action is required at this time.This investigation is now complete.(b)(4).H.M.(b)(6) 2022.
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