BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE 2991

    MDR report key: 2421384 · Received January 10, 2012

    Report

    Report Number
    1722028-2012-00029
    Event Type
    Other
    Date Received
    January 10, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 14, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    CAC
    PMA / PMN Number
    K893962
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE USING THEIR COBE 2991 MACHINE, MOST OF PROCESSED RED CELLS WENT TO THE WASTE BAG, AND THERE WERE JUST A FEW OF RED CELLS IN THE PROCESSING BAG POST PROCEDURE. THEY WERE PERFORMING DEGLYCEROLIZATION OF FROZEN RED BLOOD CELLS. THE CUSTOMER REPORTED THAT THEY WERE USING THE SOP ACCORDING TO OUR OPERATOR'S MANUAL. THIS ISSUE HAPPENED ONE TIME AND THE REMAINING PROCEDURES WERE OK. THE USED FLUIDS WERE THE SAME AS THE PREVIOUS PROCEDURES. THE CUSTOMER DIDN'T TEST THE PRODUCT IN THE PROCESSING BAG AND THE WASTE BAG, BUT CONFIRMED HEMOLYSIS OCCURRED BY VISUAL INSPECTION ONLY. THE CUSTOMER DISCARDED THE PROCESSED PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PT INVOLVED AT THE TIME OF THE CELL PROCESSING, THEREFORE NO PT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. IT IS UNKNOWN AT THIS TIME IF THE DISPOSABLE SET IS AVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION RESULTING IN CELL HEMOLYSIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE 2991 APPARATUS, AUTOTRANSFUSION CAC CARIDIANBCT 04S15002

    Patients

    Seq Age Sex Outcome Treatment
    1