BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOLAB ORS HUSH SLUSH DRAPE

    MDR report key: 3899203 · Received June 4, 2014

    Report

    Report Number
    3899203
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 28, 2014
    Manufacturer
    MICROTEK MEDICAL INC
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IRRIGATION SOLUTION WARMER, WITH SLUSH/WARMER DISC DRAPE WAS BEING USED ON A SURGICAL CASE. WHEN THE CASE WAS COMPLETE, FLUID WAS NOTED UNDER THE DRAPE. THE RESERVOIR WAS DRIED AND THE SAME DRAPE WAS REAPPLIED, AGAIN FLUID WAS DRIPPING FROM UNDER THE DRAPE. NO HOLE COULD BE SEEN IN THE DRAPE. NO KNOWN HARM TO THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327833 ECOLAB ORS HUSH SLUSH DRAPE DRAPE KKX MICROTEK MEDICAL INC ORS-321 D133331
    327834 ECOLAB ORS HUSH SLUSH SYSTEM WARMER, IRRIGATION MACHINE KKX MICROTEK MEDICAL INC ORS-1075HS *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR SOLUTION WARMER SERIAL # (B)(4)| NO OTHER THERAPIES