BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA WHITE BLOOD CELL SET, CLOSED

    MDR report key: 2132475 · Received June 13, 2011

    Report

    Report Number
    1722028-2011-00174
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK020041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROGRESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN APHERESIS PROCEDURE WAS PERFORMED ON A PEDIATRIC PT. SHE WAS UNDER (B)(6), THEREFORE, A BLOOD PRIME WAS PERFORMED. THE PT WAS ATTACHED ONCE THE COLLECTION SET WAS LOADED AND PRIMED WITH SALINE AND THE BLOOD PRIME WAS COMPLETED. THE PROCEDURE STARTED WITH NO COMPLICATION. HOWEVER, AS THE CELLS BEGAN TO BE PUSHED UP THROUGH TO THE COLLECTION BAG, A LEAK BECAME EVIDENT SOMEWHERE ON THE LINE. THE CUSTOMER REPORTED THAT FLUID WAS 'MISTLING' INTO THE AIR. THE MACHINE WAS STOPPED AND THE RUN ABORTED. THERE WAS NO OBVIOUS SPLIT IN THE LINE ON VISUAL INSPECTION. THERE WAS ALSO A SPLIT IN THE BLOOD WARMER GIVING SET WHEN THE LINE WAS PRIMED PRIOR TO BEING CONNECTED TO THE PT. THE LINE WAS REPLACED AND NO FURTHER PROBLEMS WERE ENCOUNTERED WITH THE BLOOD WARMER. CARIDIANBCT IS AWAITING THE RETURN OF THE DISPOSABLE. THE CUSTOMER MENTIONED MEDICAL INTERVENTION, BUT NO FURTHER INFO IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA WHITE BLOOD CELL SET, CLOSED SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 02T15228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention