BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY MX - TRUEBEAM

    MDR report key: 2218215 · Received August 11, 2011

    Report

    Report Number
    2916710-2011-00109
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K092871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT A PINNACLE PLAN WAS TRANSFERRED TO ARIA AND A GENERIC REFERENCE POINT ID OF "BEAM DOSE POINT" WAS CREATED FOR THE PLAN FIELDS. THE REFERENCE POINT ID WAS EDITED AND TOTAL DOSE VALUE SET FOR THE REFERENCE POINT WAS (B)(4). AS OF (B)(6) 2011, (B)(4) WAS DELIVERED USING THIS REF POINT (200 CGY WAS DELIVERED TO THIS PLAN USING A DIFFERENT MACHINE, BUT WAS NOT RECORDED AND A DOSE CORRECTION WAS ADDED TO THE CHART TO MAKE UP THE 5000). A BOOST PLAN WAS GENERATED IN PINNACLE AND SENT TO ARIA AND THE BEAMS FOR THAT PLAN WERE DEFAULTED SO AS TO CONTRIBUTE TO THE SAME REFERENCE POINT BUT AT THAT TIME THE REFERENCE POINT NAME WAS CHANGED AS WELL AS THE TOTAL DOSE LIMIT VALUE, FROM (B)(4). ON (B)(6) 2011 THE BOOST PLAN WAS MODED UP AT TRUEBEAM BUT THE THERAPISTS WERE NOT PREVENTED FROM TREATING, EVEN THOUGH THE TOTAL DOSE LIMIT FOR THE REFERENCE POINT HAD BEEN EXCEEDED. ALL SUBSEQUENT DAYS THE BOOST PLAN WAS TREATED, THE THERAPISTS HAVE NOT BEEN PROMPTED WITH ANY MESSAGES/WARNINGS/OVERRIDES REGARDING THE TOTAL REFERENCE POINT DOSE BEING EXCEEDED; THEY HAVE BEEN ALLOWED TO TREAT WITHOUT ISSUE. NO MISADMINISTRATION OR SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY MX - TRUEBEAM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H19

    Patients

    Seq Age Sex Outcome Treatment
    1