BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMICUS APHERESIS KIT, CLOSED, SGL. NEEDLE

    MDR report key: 509968 · Received February 5, 2004

    Report

    Report Number
    1420141-2004-00003
    Event Type
    Death
    Date Received
    February 5, 2004
    Date of Event
    January 15, 2004
    Report Date
    January 22, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE REGIONAL QUALITY DIRECTOR AT THE COLLECTION FACILITY REPORTED A PT EXPERIENCED A TRANSFUSION REACTION 15 MINUTES INTO THE TRANSFUSION. APPROXIMATELY 50 CC OF A SINGLE DONOR PLATELET PRODUCT HAD BEEN ADMINISTERED WHEN THE PT DEVELOPED SYMPTOMS OF CHILLS, RIGORS, NAUSEA, SHORTNESS OF BREATH, AND AN INCREASE IN HEART RATE FROM 84 TO 105. THERE WAS NO IMMEDIATE CHANGE IN TEMPERATURE OR BLOOD PRESSURE. THE PT RECEIVED ANTIBIOTICS AND PRESSORS, AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. SERVERAL HOURS LATER THE PTS TEMPERATURE ROSE TO 103 F AND THEIR BP FELL TO 65 SYSTOLIC, WITH A HEART RATE OF 165. IN 2004, THE PT DEVELOPED RENAL FAILURE, VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION, ASYSTOLE AND SUBSEQUENTLY EXPIRED. PRIOR TO THE TRANSFUSION, THE PT HAD BEEN ON ANTIHISTMINES AND STEROIDS (NAME, DOSE AND ROUTES UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICUS APHERESIS KIT, CLOSED, SGL. NEEDLE AMICUS APHERESIS KIT GKT BAXTER HEALTHCARE CORP. NA N03J22027

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death AMICUS SEPARATOR.