BEUDAMED
    FDA Adverse Event Death Summary report: N

    H-1025

    MDR report key: 513791 · Received February 24, 2004

    Report

    Report Number
    1221261-2004-00007
    Event Type
    Death
    Date Received
    February 24, 2004
    Date of Event
    December 12, 2003
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THAT THE PT DIED AS A RESULT OF AN AIR EMBOLISM. THE PT WAS SEVERELY UNWELL TRAUMA PT WHO HAD BEEN INVOLVED IN A CAR ACCIDENT. THE AUTOPSY REPORT FROM THE HOSP WAS ALLEGED TO CONLUDE THE CAUSE OF DEATH TO BE AIR EMBOLISM. DURING TREATMENT THE PT WAS REPORTED TO HAVE RECEIVED AN INFUSION USING THE LEVEL 1 FLUID WARMER. MODEL H-1025. WITH A DI-50 I.V. ADMINISTRATION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-1025 FAST FLOW FLUID WARMER LGZ SMITHS MEDICAL ASD, INC. H-1025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death