BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER HEALTHCARE CORP

    MDR report key: 528077 · Received May 18, 2004

    Report

    Report Number
    MW1032109
    Event Type
    Injury
    Date Received
    May 18, 2004
    Date of Event
    May 12, 2004
    Report Date
    May 18, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A PLATELET APHERESIS PROCEDURE USING THE BAXTER AMICUS CELL SEPARATOR, THE OPERATOR NOTICED HEMOLYSIS IN THE DONOR'S PLASMA IN THE KIT LINES AND PLASMA COLLECTION BAG. IMMEDIATELY BEFORE STOPPING THE PROCEDURE A SECOND OPERATOR NOTICED THAT THE MIDDLE AND RIGHT CASSETTES WERE "CONTAMINATED" WITH RED CELLS. THE PROCEDURE HAD RUN FOR ABOUT 30 MINUTES PROCESSING 1431 ML OF WHOLE BLOOD. 200 ML OF ACD WERE USED AND 383 ML OF SALINE WERE INFUSED. DURING AND AFTER THE PROCEDURE, THE DONOR FELT FINE HOWEVER, A URINE COLLECTED POST-PROCEDURE WAS RED AND HAD OCCULT BLOOD AND PROTEIN. BLOOD SPECIMENS WERE COLLECTED FOR ADDITIONAL TESTING AND THE DONOR WAS ADMITTED TO THE HOSP OVERNIGHT. BAXTER WAS NOTIFIED OF THE EVENT. THIS PIECE OF EQUIPMENT HAD BEEN SERVICED THE NIGHT BEFORE AND THIS WAS THE FIRST USE AFTER SERVICE. THE SAME KIT LOT# HAD BEEN USED SEVERAL TIMES FOR OTHER COLLECTIONS. BAXTER IS PARTICIPATING IN EVALUATING THE EVENT, KIT, AND EQUIPMENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER HEALTHCARE CORP AMICUS CELL SEPARATOR, SOFTWARE VERSION 2.51 GKT BAXTER HEALTHCARE CORP. 4R4580 N03K21019/11-04

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization