BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2379422 · Received September 21, 2011

    Report

    Report Number
    2916710-2011-00125
    Event Type
    Other
    Date Received
    September 21, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 24, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN'S INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT REASON THAT THE MLC DISAPPEARED. VARIAN HAS INVESTIGATED THE ISSUE TO BEST OF ITS KNOWLEDGE AND ALL INFO AVAILABLE, AND THERE IS NO INDICATION THAT THE DEVICE HAS MALFUNCTIONED. THE INVESTIGATION CONCLUDES THAT MOST PROBABLY USER HAS UNINTENTIONALLY DELETED THE MLC ACCESSORY FROM THE PLAN WHILE THEY DID OTHER MODIFICATIONS TO THE PLAN. NO ROOT CAUSE FOR THIS ISSUE CAN BE DETERMINED SINCE VARIAN CAN NOT CONCLUSIVELY PROVE THAT A USER DELETED AN MLC AND THE ISSUE HAS NOT BEEN REPRODUCIBLE. CORRECTIVE ACTION: VARIAN HAS ISSUED A DISCREPANCY REPORT (DR) TO ADD LOGGING ON THE PT EDITING LOG TABLE OF ALL MLC AND ACCESSORY DELETIONS THAT OCCUR PRIOR TO A PLAN BEING APPROVED. (IT IS OTHERWISE NOT POSSIBLE TO CONCLUSIVELY DETERMINE THAT A MLC HAS BEEN DELETED). VARIAN WILL CONTINUE TO MONITOR THIS SITE AND TREND ANY ADD'L REPORTS OF THIS ISSUE. NO ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THEY EXPORTED A PLAN FROM PINNACLE TO RTPX THEN IMPORTED INTO ARIA; THIS WAS AN IMRT PLAN AND WHEN PERFORMING THE PLAN QA ON THE TREATMENT MACHINE, THE CUSTOMER FOUND ONE OF THE TREATMENT FIELDS HAD LOST THE PLANNED MLC AND WAS BEING DELIVERED AS AN OPEN FIELD. UPON INVESTIGATION WITHIN RT CHART / PARAMETERS TAB, THERE WERE NO MLC ATTACHED TO THIS FIELD FOR BOTH THE TREATMENT PLAN AND THE VERIFICATION PLAN. THE DOSIMETRIST RE-EXPORTED THE PLAN FROM PINNACLE TO RTPX THEN IMPORTED INTO ARIA AND THE MLC WAS PRESENT WITH THE SECOND IMPORT. THERE WAS NO SERIOUS INJURY REPORTED AS A RESULT OF THIS ISSUE. THE ISSUE WAS DISCOVERED DURING THE PLAN QA AND WAS RESOLVED PRIOR TO TREATING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONCOLOGY ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. HIT

    Patients

    Seq Age Sex Outcome Treatment
    1