System was used for treatment.Kit lot e339 was reviewed.There were no non-conformances.This lot met all release requirements.The (b)(4) lot number was not provided as it was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories alarm #46: accelerometer system alarm, drive tube leak/break and alarm #7: blood leak: (centrifuge chamber) and no trend was detected for these categories.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned.
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Customer called to report alarm #46: accelerometer, system alarm, drive tube leak/break and alarm #7 blood leak (centrifuge chamber) during the procedure.Customer said following the alarm, they opened up the centrifuge door and observed blood to have leaked through a "crack" in the drive tube wall.Customer said both the centrifuge bowl, and drive tube bearings were still correctly latched in place.Customer said there did not appear to be any damage to any of the components as per her visual inspection.Customer denied the need for service, and said they were able to clean up the leak themselves without any issues.Customer said the patient was stable, that they aborted the procedure, and did not give any fluid back to the patient.Customer said she would call back if she experienced any further issue.
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