BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA WHITE BLOOD CELL SET-FUNCTIONALLY CLOSED

    MDR report key: 2887641 · Received December 19, 2012

    Report

    Report Number
    MW5028328
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 15, 2012
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS SET-UP FOR A STEM CELL COLLECTION AND ONCE THE PROCEDURE STARTED A SMALL AMOUNT OF FLUID WAS NOTED TO BE LEAKING FROM THE COLLECTION BAG TUBING. UPON ASSESSMENT IT WAS NOTED THAT THE LEAKING WAS COMING FROM THE CONNECTION BELOW THE ACDA FILTER. THE CONNECTION WAS LOOSE AND NOT PROPERLY SEALED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA WHITE BLOOD CELL SET-FUNCTIONALLY CLOSED COBE WBC PROCEDURE KIT GKT TERUMO BCT, INC. 08U15206

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention