BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIAN 4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 4151927 · Received October 6, 2014

    Report

    Report Number
    2916710-2014-00006
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 22, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K133331
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO FAILURE OR MALFUNCTION OF VARIAN HARDWARE OR SOFTWARE. THIS EVENT OCCURRED AS A RESULTS OF USER ERROR AND INATTENTION. THE CUSTOMER TREATED THE PATIENT WITH A QA PLAN AS OPPOSED TO A TREATMENT PLAN DESPITE A WARNING BEING DISPLAYED. NO ADDITIONAL FOLLOW UP TO THIS REPORT IS ANTICIPATED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS IRRADIATED USING A QUALITY ASSURANCE PLAN (QA) OF AN EXTRA-CRANIAL RADIOSURGERY INTENSITY MODULATED RADIATION THERAPY (IMRT INSTEAD OF A TREATMENT PLAN. THE CUSTOMER CONDUCTED A QA DRY-RUN ONE DAY BEFORE THE SCHEDULED TREATMENT USING THE QA PLAN AND FILM WITH ANTICIPATED RESULTS. THE FOLLOWING DAY, THE PATIENT WAS POSITIONED ON THE TABLE TO TREATMENT, AND THE THERAPIST LOADED THE TREATMENT PLAN IN 4DTC, CHECKED WITH A PRINTED, APPROVED, TREATMENT PLAN (WHICH IS THE CUSTOMER'S ROUTINE FIRST DAY OF TREATMENT OR FOR SRS TREATMENTS). THE CHECKS PASSED AND BEFORE THE THERAPIST STARTED IRRADIATION, THE PATIENT HAD A FULL BLADDER THAT COULD NOT WAIT FOR TREATMENT. SO THE PATIENT WAS ALLOWED TO LEAVE THE TREATMENT ROOM AND A WAITING PATIENT WAS BROUGHT IN TO FILL THE TIME WITH NORMAL RESULTS. AFTER THAT THE FIRST PATIENT RETURNED TO THE TREATMENT ROOM, WAS REPOSITIONED, BUT INSTEAD OF UPLOADING THE TREATMENT PLAN, THE THERAPIST UPLOADED THE QA PLAN. THE THERAPY FAILED TO CHECK THE 4DITC PLAN PARAMETERS AGAINST THE APPROVED PLAN AS PREVIOUSLY DONE. ONE OF THE PRIMARY DIFFERENCES BETWEEN THE QA AND TREATMENT PLANTS IS THE AQ PLAN DELIVERS RADIATION FROM A FIXED GANTRY ANGLE. THE TREATMENT PLAN WOULD HAVE DELIVERED EACH FIELD FROM DIFFERENT GANTRY ANGLES. THE THERAPIST ONLY REALIZED THE PROBLEM WHILE DELIVERING THE LAST FIELD, AT WHICH TIME IRRADIATION WAS STOPPED, AFTER APPROXIMATELY 50% OF THE DOSE FOR THAT FIELD WAS DELIVERED. THE FIRST 6 FIELDS FULLY DELIVERED 100% OF THE PLANNED DOSE. ACCORDING TO THE HOSPITAL, EACH FIELD HAD AN 800MU AVERAGE. THE TOTAL PLANNED DOSE WAS 1,600 CGY, SCHEDULED TO BE DELIVERED IN ONE SESSION. THE INTENDED TREATMENT REGION WAS THE L4 VERTEBRAE. AS A RESULT OF THE ERROR, THE ACTUAL TREATMENT REGION WAS THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622498 VARIAN 4D INTEGRATED TREATMENT CONSOLE SYSTEM PLANNING RADIATION THERAPY TX MUJ VARIAN MEDICAL SYSTEMS, INC. H51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other