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.The kit lot number was not provided; therefore, a batch record review was not performed.Trends were reviewed for complaint categories, pressure dome leak and alarm #18: system pressure.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.Section 4-22 of the cellex operators manual (1470493_rev06) states: "caution: do not remove any pressure dome during treatment".The operator reported they removed the system pressure dome during the treatment; therefore, the root cause for the pressure dome leak is most likely due to use error.No further action is required at this time.This investigation is now complete.(b)(4) on (b)(6) 2024.
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