The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl 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 l152 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l152 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.The kit and smart card were not returned.A visual inspection of the customer provided photographs verified the bowl break.There is a pool of blood at the bottom of the centrifuge chamber and blood splatters on the walls of the centrifuge chamber.It appears that the centrifuge bowl had dislodged out of the bowl holder and impacted the leak detector strip inside the centrifuge chamber during the treatment.A known cause for the centrifuge bowl to dislodge out of the bowl holder is due to the centrifuge bowl not properly locked into the bowl holder during the installation.A material trace of the drive tube assembly and its components used to build lot l152 found no related non-conformances.A device history record (dhr) review did not identify any related non-conformances, deviations, or equipment maintenance events.This lot passed all lot release testing.The root cause of the centrifuge bowl leak/break could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).N.S.(b)(6) 2023.
|