BEUDAMED
    FDA Adverse Event Other Summary report: N

    L-70NI FLUID ADMINISTRATION SET

    MDR report key: 290789 · Received July 28, 2000

    Report

    Report Number
    1221261-2000-00003
    Event Type
    Other
    Date Received
    July 28, 2000
    Date of Event
    July 4, 2000
    Report Date
    July 24, 2000
    Manufacturer
    SIMS LEVEL 1, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIMS LEVEL 1, INC. REC'D A REPORT FROM HOSP, THAT DURING A SURGICAL PROCEDURE THE WATER BATH OF THE FLUID WARMER WAS OVERFLOWING. THE SET WAS DISCONNECTED FROM THE PT AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-70NI FLUID ADMINISTRATION SET DISPOSABLE FLUID WARMING ADMINISTRATION SET LGZ SIMS LEVEL 1, INC. L-70NI 200003B

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other