BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEL 1 FLUID WARMER

    MDR report key: 526984 · Received May 24, 2004

    Report

    Report Number
    1221261-2004-00016
    Event Type
    Death
    Date Received
    May 24, 2004
    Date of Event
    November 1, 2001
    Report Date
    May 21, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL ASD, INC. WAS NOTIFIED THAT IN 2001 A PT WAS UNDER GOING BACK SURGERY, INCLUDING TREATMENT WITH THE USE OF A LEVEL 1 FLUID WARMER, AND SUFFERED A MASSIVE VENOUS EMBOLISM AND RESULTED IN PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 FLUID WARMER FLUID WARMER LGZ SMITHS MEDICAL ASD, INC. NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death