BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREASSEMBLED SURGICAL WASH SET

    MDR report key: 497758 · Received November 17, 2003

    Report

    Report Number
    1718850-2003-00024
    Event Type
    Other
    Date Received
    November 17, 2003
    Date of Event
    November 6, 2003
    Report Date
    November 17, 2003
    Manufacturer
    DIDECO SPA.
    Product Code
    CAC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NURSE OPERATING THE DEVICE ATTEMPTED TO EMPTY THE WASTE BAG DURING A CYCLE (WHILE THE BOWL WAS SPINNING). THE BOWL LINE BECAME DISCONNECTED FROM THE WASTE BAG AND THEY ATTEMPTED TO RE-ATTACH THE LINE. AT THAT POINT BLOOD BEGAN TO SPRAY FROM AROUND THE ROTATING SEAL OF THE CENTRIFUGE BOWL AND APPARENTLY A SMALL AMOUNT OF THE BLOOD SPRAYED OUT OF THE CENTRIFUGE WELL AND ONTO THE NURSE. THE ATS COORDINATOR FEELS THAT THE NURSE SOMEHOW OCCLUDED THE LINE WHILE ATTEMPTING TO RE-ATTACH IT AND THE BACK PRESSURE FROM THE OCCLUDED LINE CAUSED THE ROTATING SEAL TO OPEN. THERE WAS NO PT INVOLVEMENT AND MINIMUM BLOOD LOSS IN THE CENTRIFUGE WELL AT THE END OF THE PROCEDURE. NO INTERVENTION WAS REQUIRED. THE ATS COORDINATOR INDICATES THAT THIS WAS OPERATOR ERROR AND THERE IS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREASSEMBLED SURGICAL WASH SET AUTOTRANSFUSION SET CAC DIDECO SPA. NA 0305260094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other