BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2924790 · Received January 3, 2013

    Report

    Report Number
    2924790
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    September 21, 2012
    Report Date
    January 2, 2013
    Manufacturer
    OR SOLUTIONS, INC
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF THE IRRIGATION DRAPE FROM THE IRRIGATION WARMER, THE RN NOTICED THERE WAS FLUID IN THE BOTTOM OF THE WARMER. SHE BEGAN INSPECTING THE DRAPE FOR A HOLE. THE CHARGE NURSE WAS NOTIFIED AND TOOK A PICTURE OF THE FLUID. SHE LAYERED THE DRAPE ON THE TABLE TO DRY. AFTER THE DRAPE WAS DRY, SHE POURED IRRIGATION INTO THE DRAPE TO SEE IF THERE WAS A LEAK. FLUID BEGAN DRIPPING OUT THE BOTTOM OF THE DRAPE THROUGH A PIN-SIZE HOLE. THERE WERE NO HOLES IDENTIFIED IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3720 * DRAPE, FLUID WARMER KKX OR SOLUTIONS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR