The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction photoactivation module 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 j360 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j360 shows no trends.Trends were reviewed for complaint categories, photoactivation module leak and alarm #8: blood leak? (photoactivation chamber).No trends were detected for these complaint categories.Photographs were provided by the customer for evaluation.The complaint kit was not returned.A review of the photographs verify the photoactivation module leak as blood is seen leaking through a crack in the photoactivation module.A material trace of the photo plate halves used in lot j360 found no related non-conformances.The device history record (dhr) review did not result in any related non-conformances and this kit lot passed all lot release testing.All photoactivation plates are inspected prior to packaging; therefore, it is unlikely the cracks to the photoactivation module were present at the time of manufacturing.The cause of the alarm #8: blood leak? (photoactivation chamber) was most likely due to the leak in the photoactivation chamber.The root cause of the photoactivation module leak was due to the cracks in the plate; however, the cause for the cracks could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6) 2021.
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