BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 2422967 · Received December 14, 2011

    Report

    Report Number
    3003793371-2011-00048
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 15, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT ALLEGATION WAS CONFIRMED - DELTA COUCH SHIFT IS RETAINED ON COPIED PLANS - THERE IS NO WARNING THAT THE DCS VALUES ARE BEING TRANSFERRED WITH THE COPIED PLAN; UNAPPROVED PLANS DO NOT RECEIVE A WARNING AT EXPORT. ROOT CAUSE: DESIGN DEFICIENCY-ONCE THE DCS VALUES HAVE BEEN POPULATED, THEY REMAIN IN THE PLAN, EVEN IF THE PLAN IS COPIED OR THE ORIGINAL PLAN CHANGES ISOCENTER. THE ONLY WAY TO HAVE THE PROPER DCS VALUES IS TO ISSUE PLANNING APPROVAL WITH THE DCS EDITOR OPTION SELECTED IN ADMIN. ALSO, ONCE THE DCS VALUES ARE POPULATED IN A PLAN, THE COUCH SHIFT ICONS AND DCS WILL BE PRESENT IN THE PRINTOUT OR WHEN THE PLAN IS EXPORTED. WHEN THE DCS EDITOR IS DE-SELECTED THE WARNING MESSAGE OF THE DCS DIFFERENCES ONLY APPEAR DURING THE TREATMENT APPROVAL PROCESS OR EXPORT OF AN APPROVED PLAN. UNAPPROVED PLANS DO NOT GET A WARNING MESSAGE. WHEN THE DCS IS SELECTED, THE WARNING MESSAGE IS IN THE PLANNING AND THE TREATMENT APPROVAL PROCESS BUT NOT PRESENT ON EXPORT OF UNAPPROVED PLANS. VARIAN IS NOT AWARE OF ANY PT MISTREATMENT OR SERIOUS INJURY AS A RESULT OF THIS ISSUE. CORRECTIVE ACTION: A CHANGE REQUEST WILL BE SUBMITTED TO ADDRESS THIS ISSUE IN FUTURE RELEASE VERSION OF ECLIPSE. NOTIFICATION WILL BE MADE TO CUSTOMERS REGARDING THIS ISSUE. NO ADDITIONAL F/U TO THIS MDR IS ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER COPIED AND PASTED ORIGINAL, APPROVED PLAN TO USE A BOOST PLAN ON THE SAME CT 3D IMAGE. IN THE BOOST PLAN, THE FIELD ISOCENTER WAS CHANGED. THE PLAN REPORT WAS GENERATED BEFORE THE PLAN APPROVAL HAS ISSUES. THE UNAPPROVED PLAN STILL RETAINED THE ORIGINAL DELTA COUCH SHIFT VALUES. THE THERAPIST REVIEWS THE PRINTED PLAN REPORT COMPARED TO THE ISOCENTER LOCATION OF THE FIELDS IN ARIA AND DISCOVERS THE MISMATCH WHICH CAUSED SOME CONFUSION ON WHAT WAS THE CORRECT ISOCENTER SHIFT VALUE. AT THIS SITE, THE DOCTOR ISSUED THE PLAN APPROVAL AND TREAT APPROVAL JUST BEFORE TREATMENT OF THE PT. NO PT INJURY REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM SYSTEM, PLANNING, RADIATION THERAPY TREAT MUJ VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS H48B

    Patients

    Seq Age Sex Outcome Treatment
    1