BEUDAMED
    FDA Adverse Event Death Summary report: N

    D-301 IV FLUID ADMINISTRATION SET

    MDR report key: 305786 · Received November 16, 2000

    Report

    Report Number
    1221261-2000-00004
    Event Type
    Death
    Date Received
    November 16, 2000
    Date of Event
    November 8, 2000
    Report Date
    November 16, 2000
    Manufacturer
    SIMS LEVEL 1, INC.
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIMS LEVEL 1, INC. WAS NOTIFIED BY HOSP THAT DURING A SURGICAL PROCEDURE, THE FLOAT BALL IN THE VORTEX GAS VENT ASSEMBLY DROPPED, STOPPING THE FLOW OF FLUID TO THE PT. IN SUCH EVENT, THE INSTRUCTIONS FOR USE DETAIL THE PROCEDURE TO RE-FLOAT THE BALL VALVE. HOSP STATED THAT THEY DID NOT ATTEMPT TO RE-FLOAT THE BALL VALVE, BUT REMOVED THE VORTEX GAS VENT ASSEMBLY, TEMPORARILY BYPASSING THE ADMINISTRATION SET, AND REPLACED THE VORTEX GAS VENT ASSEMBLY WITH AN F-30 GAS VENT ASSEMBLY. FLUID ADMINISTRATION RESUMED, AND FLOWED "FINE". THE PT WHO WAS ADMITTED TO THE HOSP FOR INJURIES SUSTAINED IN A MOTOR VEHICLE ACCIDENT SUBSEQUENTLY DIED DURING SURGERY DUE TO MULTIPLE TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-301 IV FLUID ADMINISTRATION SET NORMOTHERMIC WARMING DEVICE LGZ SIMS LEVEL 1, INC. D-301 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death| O