BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM ULTRASONICS

    MDR report key: 1295784 · Received January 26, 2009

    Report

    Report Number
    2523209-2009-00003
    Event Type
    Other
    Date Received
    January 26, 2009
    Date of Event
    December 5, 2008
    Report Date
    January 23, 2009
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FLG
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SIX YEAR OLD MACHINE DEVELOPED HARD DRIVE DIFFICULTIES RESULTING IN THE NEED FOR REPLACEMENT. REPLACEMENT WAS SUPPLIED BY CU, INSTALLED AND USED TO RUN WASH/DISINFECTANT CYCLES FOR 45 PATIENTS UNTIL THE IMMERSION TIME ERROR WAS DISCOVERED. RISK OF INFECTION, ALTHOUGH UNLIKELY, IS POSSIBLE FROM INSUFFICIENT IMMERSION TIME FOR FLEXIBLE ENDOSCOPES WHEN USING THE CIDEX PRODUCT ACCORDING TO LABELING. ROOT CAUSE IS EMPLOYEE ERROR FOR NOT CONFIRMING DISINFECTANT TYPE, TIME AND TEMPERATURE. CALIBRATION CHANGE WAS MADE AND SYSTEM IS FUNCTIONING AS REQUIRED FOR CIDEX DISINFECTANT.

    Description of Event or Problem · 1

    FORTY FIVE PTS WERE ENDOSCOPED OVER A 20 DAY PERIOD USING ENDOSCOPES DISINFECTED WITH CIDEX GLUTARALDEHYDE DISINFECTANT CHEMICAL FOR 5 MINUTE IMMERSION AT 25DEG C. CIDEX LABELING CALLS FOR 45 MIN IMMERSION AT 25DEG C. ALTHOUGH UNLIKELY, THIS CONDITION MAY CREATE THE POTENTIAL FOR RISK OF INFECTION TO THESE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS ENDOSCOPIC REPROCESSOR/DISINFECTOR FLG CUSTOM ULTRASONICS, INC. SYSTEM 83 PLUS 2 EQ 1690-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other