BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASP

    MDR report key: 651970 · Received November 9, 2005

    Report

    Report Number
    651970
    Event Type
    Other
    Date Received
    November 9, 2005
    Date of Event
    July 13, 2005
    Report Date
    July 19, 2005
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS, J J
    Product Code
    FEB
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    UPON INSTALLATION OF A NEW REPROCESSOR THE DISINFECT TIME AND WASH TIME WERE INVERTED. INSTEAD OF 5 MINUTE DISINFECT AND 1 MIN. WASH, THE CYCLES WERE SWITCHED. THIS WAS NOTICED BY THE MANUFACTURER'S REPRESENTATIVE AFTER AN OLDER MACHINE OVERFILLED AND THE MANUFACTURER WAS CALLED IN TO FIX IT. THE SECOND MACHINE TIMES ALSO HAD BEEN INVERTED AFTER RESETTING IT SO THAT THE DISINFECTANT COULD BE DRAINED OUT OF THE TUB INTO THE BASIN. ALL PATIENTS, PHYSICIANS AND THE STATE HAVE BEEN NOTIFIED. ROOT CAUSE ANALYSIS HAS BEEN PERFORMED AND CORRECTIVE ACTIONS TO PREVENT THIS HAVE BEEN IMPLEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP ENDOSCOPY REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS, J J 387P-2 *
    2 ASP ENDOSCOPY REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS, J J 387P-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *