BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOURCE

    MDR report key: 1361175 · Received January 29, 2009

    Report

    Report Number
    8020711-2009-00002
    Event Type
    Malfunction
    Date Received
    January 29, 2009
    Date of Event
    December 15, 2008
    Report Date
    January 29, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KXK
    PMA / PMN Number
    K061582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON INFORMATION RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS. WHILE THE REPORTED EVENT IS BEING INVESTIGATED, SOME OF THE FACTS ARE AS YET UNVERIFIED. BY SUBMITTING THIS REPORT, THE COMPANY IS NOT ADMITTING THAT THE PRODUCT IDENTIFIED HAS MALFUNCTIONS, IS DEFECTIVE, OR HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH. INFORMATION PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFORMATION CURRENTLY AVAILABLE IS TRUE AND ACCURATE.

    Description of Event or Problem · 1

    ERROR DESCRIPTION: WHILE PERFORMING THE FINAL POSITION VERIFICATION AFTER A ROUTINE SOURCE EXCHANGE ON THE VARISOURCE 200 AFTERLOADING DEVICE THE FIELD SERVICE REPRESENTATIVE RECEIVED AN ERROR MESSAGE "1A ACTIVE WIRE PATH CONSTRICTION AT 83.5 CM" AND FOLLOWING THE SYSTEM ENGAGED THE EMERGENCY RETRACT MECHANISM. THE EVOLUTION OF THE HAND WHEEL GOT SLOWER AND SLOWER AND THE VARISOURCE 200 REPORTED THAT A MANUAL RETRACT WAS NECESSARY. IT WAS OBSERVED THAT THE INDEPENDENT ROOM MONITORING DEVICE STILL INDICATED RADIATION IN THE TREATMENT ROOM. THIS WAS AN INDICATION THAT THE ACTIVE SOURCE WIRE WAS NOT IN ITS PARKING POSITION. A MANUAL RECOVERY WAS NECESSARY. WITHIN THIS EVENT NO PATIENT WAS INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other