BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOURCE IX HDR BRACHYTHERAPY AFTERLOADER

    MDR report key: 2142563 · Received June 20, 2011

    Report

    Report Number
    8020711-2011-00005
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS UK LTD.
    Product Code
    JAQ
    PMA / PMN Number
    K071467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION FOUND THAT THE NEWLY INSTALLED ACTIVE WIRE BECAME STUCK IN THE WEDGE BLOCK OF UNIT DUE TO AN INGRESS OF CONTAMINATION THAT WAS LIKELY INTRODUCED INTO THE SYSTEM WHEN THE ACTIVE WIRE WAS LOADED. THIS INDICATES THAT THE CONTAMINATION WAS CARRIED INTO THE SYSTEM ON THE ACTUAL SOURCE WIRE. IT IS NOT KNOWN IF THE SOURCE WIRE WAS CONTAMINATED PRIOR TO SHIPPING OR CONTAMINATED DUE TO THE SHIPPING PROCESS. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AFTER COMPLETING THE INSTALLATION OF THE AFTERLOADER, ALL OF THE NORMAL MAINTENANCE/PERFORMANCE CHECKS AND THE PORTION OF THE CUSTOMER ACCEPTANCE PROCEDURE, THE ACTIVE SOURCE WIRE WAS LOADED INTO THE MACHINE AND SUBSEQUENTLY BECAME STUCK WHILE PARKED IN THE SAFE. AFTER LOADING THE NEW DUMMY WIRE AND THE ACTIVE SOURCE WIRE, FSE WAS CYCLING BOTH NEW WIRES FOR A FEW CYCLES THROUGH A LENGTH OF PTFE CATHETER WHEN AFTER A FEW CYCLES THE SOURCE WIRE BEGAN TO STRUGGLE TO MOVE. THE SYSTEM GENERATED AN ACTIVE DRIVE SLIPPAGE ERROR AND AN EMERGENCY RETRACT MOTOR ACTIVE ERROR. AFTER A PRELIMINARY INVESTIGATION OF THE CATHETER AND MECHANICAL INSPECTION SHOWED NOTHING AMISS, FSE ATTEMPTED TO UNLOAD THE SOURCE WIRE, BUT WAS UNABLE TO DO SO. AT THAT POINT, THE APPROPRIATE PEOPLE WERE NOTIFIED AND A RECOVERY TEAM WAS SENT IN. DURING THE RECOVERY IT SEEMED THAT THE WIRE WAS STUCK AT THE WEDGE BLOCK LOCATED BETWEEN THE V-DRIVE AND THE ENCODER ASSEMBLY. THE ENTIRE ENCODER ASSEMBLY INCLUDING THE WEDGE BLOCK WAS SENT TO THE (B)(4) MANUFACTURING FACILITY FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISOURCE IX HDR BRACHYTHERAPY AFTERLOADER SYS, APPLICATOR, RADIONUCLIDE, R-C JAQ VARIAN MEDICAL SYSTEMS UK LTD. H60

    Patients

    Seq Age Sex Outcome Treatment
    1