BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARISOURCE

    MDR report key: 893015 · Received August 10, 2007

    Report

    Report Number
    8020711-2007-00006
    Event Type
    Other
    Date Received
    August 10, 2007
    Date of Event
    July 15, 2007
    Report Date
    August 9, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KXK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INSPECTION OF THE DEVICE ON SITE, THE FOLLOWING INFORMATION HAS BEEN CONFIRMED: YELLOW WARNING STICKER IS ATTACHED TO THE DOOR OF THE ACTIVE SIDE, JUST ABOVE THE EMERGENCY HANDCRANK INDICATING IT IS TO BE USED FOR EMERGENCY RETRACT OF THE ACTIVE WIRE ONLY. IT IS CONFIRMED THAT DURING THE FOLLOWING SERVICE VISIT, NO ADDITIONAL INDICATION FOR A DEVICE MALFUNCTION WAS FOUND.

    Description of Event or Problem · 1

    A PHYSICIST WAS PERFORMING QA CHECKS (NO PATIENT CONNECTED) ON THE VARISOURCE AFTERLOADER UNIT AND THE DUMMY WIRE BECAME STUCK IN THE "OUT" POSITION. THE PHYSICIST THEN USED THE EMERGENCY SOURCE RETURN HAND CRANK THINKING THAT ACTION WOULD RETRACT THE DUMMY SOURCE. INSTEAD, HE PULLED THE ACTIVE SOURCE (ACTIVITY 5.2 CI) FROM THE SHIELD AND CREATED AN UNCONTROLLED RADIATION AREA. THE ROOM WAS SECURED, AND THERE WAS NO ADDITIONAL RADIATION DANGER TO ANYONE. NO PATIENT INVOLVED IN THIS INCIDENT. VARIAN MEDICAL SYSTEMS SERVICE WAS CONTACTED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISOURCE BRACHYTHERAPY SYST, REMOTE AFTERLOAD KXK VARIAN MEDICAL SYSTEMS 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other