The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.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 k365 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k365 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak? (centrifuge chamber) and drive tube leak/break.No trends were detected for these complaint categories.Photographs were provided by the customer for evaluation.The complaint kit and smart card were not returned.The customer provided photographs verify the drive tube leaked at the location of the lower drive tube bearing stop.The photographs show the lower drive tube bearing is not properly installed into the drive tube retainer clip.The lower drive tube bearing is outside of the retainer, resulting in damage to the drive tube bearing stop as the procedure progressed.A known cause for a damaged drive tube is due to a misload of the drive tube bearing into bearing retainer by the end user.A material trace of the drive tubes used to manufacture lot k365 showed no non-conformances.A device history record (dhr) review did not result in any related non-conformances and this lot passed all lot release testing.The cause for the alarm #7 blood leak (centrifuge chamber) is due to the drive tube leak.The root cause for the drive tube leak is most likely due to the drive tube bearing not being secured into its retainer during installation of the kit by the end user.No manufacturing related defects were identified during this investigation.No further action is required at this time.This investigation is now complete.(b)(4).H.M.(b)(6) 2022.
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