BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA

    MDR report key: 61429 · Received January 8, 1997

    Report

    Report Number
    61429
    Event Type
    Injury
    Date Received
    January 8, 1997
    Date of Event
    December 14, 1996
    Report Date
    January 8, 1997
    Manufacturer
    COBE BCT, INC.
    Product Code
    LKN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON STARTING THERAPEUTIC PROCEDURE IT WAS NOTED THAT BLOOD WAS ENTERING VIA PLASMA AND RETURN LINES, INSTEAD OF RED CELL LINE. BLOOD WAS BEING CENTRIFUGED CLOCKWISE INSTEAD OF IN A COUNTER CLOCKWISE MOTION. RED CELLS WERE BEING DIVERTED INTO COLLECTION BAG AS OPPOSED PLASMA. PROCEDURE WAS IMMEDIATELY ABORTED, BUT NO RINSEBACK WAS POSSIBLE. PT. LOST APPROX 300 ML BLOOD. WHEN DISPOSABLE WAS EXAMINED RED CELL AND PLASMA LINES WERE CONNECTED WRONG FROM FACTORY SHIPPED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA THERAPEUTIC PLASMA EXCHANGE SET LKN COBE BCT, INC. * 07B15246

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| O| R 12/15/96-PT SIGNED OUT AMA