BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS

    MDR report key: 1841181 · Received September 16, 2010

    Report

    Report Number
    2183502-2010-00400
    Event Type
    Death
    Date Received
    September 16, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 14, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZL
    PMA / PMN Number
    BK860023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM USER FACILITY. (B)(6) FEMALE ADMITTED FOR CHILDBIRTH REQUIRED TRANSFUSIONS FOR RUPTURED UTERUS. DURING TRANSITION TO INTENSIVE CARE UNIT, IT WAS NOTED THAT THE FLUID WARMING DEVICE WAS ALARMING AND NOT FUNCTIONING CORRECTLY. TROUBLESHOOTING MEASURES PERFORMED BY FACILITY WERE UNSUCCESSFUL. PT BECAME HYPOTHERMIC (CORE TEMPERATURE MEASURED AT 31 DEGREES CENTIGRADE). APPROXIMATELY 35-50 UNITS OF BLOOD WERE TRANSFUSED IN TOTAL. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS KZL - DISPOSABLE IV FLUID WARMING SET KZL SMITHS MEDICAL ASD, INC. NA 1273874

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death