The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Review of the customer maintenance report determined the instrument's drive tube bearing clips were not damaged and did not require replacement.Therefore, the drive tube bearing clip did not likely contribute to the reported centrifuge bowl leak/break.As a result, this reportable malfunction is only associated with the kit.A batch record review for kit lot f341 was conducted.There were no non-conformances.This lot met all release requirements.A review of kit lot f341 for the reported issue shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.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.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.
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