BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHARMASEAL BLOOD/FLUID WARMER SET

    MDR report key: 35206 · Received July 24, 1996

    Report

    Report Number
    35206
    Event Type
    Injury
    Date Received
    July 24, 1996
    Date of Event
    March 12, 1996
    Report Date
    March 29, 1996
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL STAFF WAS IN THE PROCESS OF DOUBLE VOLUME EXCHANGE TRANSFUSION WHEN CONNECTION BETWEEN BLOOD WARMER CASSETTE AND TUBING TO TRANSFUSION BAG SPLIT, LOSING 100-200CC BLOOD ONTO THE FLOOR AND THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHARMASEAL BLOOD/FLUID WARMER SET BLOOD/FLUID WARMER SET LGZ PHARMASEAL DIV. BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention