BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2192585 · Received July 1, 2011

    Report

    Report Number
    3003793371-2011-00028
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, FINLAND OY
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGATION HAS BEEN CONFIRMED: PLANNED SSD NOT CLEARED WHEN COPYING PLAN FROM AN UNAPPROVED PLAN. THE POPULATION OF THE PLANNED SSD FIELD WHEN COPIED FROM AN APPROVED / AN UNAPPROVED PLAN WAS INVESTIGATED USING ECLIPSE EXTERNAL BEAM PLANNING VERSION 10.0.34. A DISCREPANCY WAS DISCOVERED WHEN THE ORIGINAL PLAN'S STATUS WAS CHANGED FROM UNAPPROVED AND APPROVED BACK TO UNAPPROVED AND THE PLAN WAS COPIED. THE NEWLY PASTED PLAN'S PLANNED SSD FIELD WAS NOT CLEARED OUT WHICH WAS THE CASE WHEN COPIED FROM AN APPROVED PLAN. ROOT CAUSE: DESIGN DEFICIENCY - THERE WAS NO SYSTEM REQUIREMENT IN PLACE TO ADDRESS THIS ISSUE. VARIAN HAS DETERMINED THAT IT IS IMPROBABLE / EXTREMELY UNLIKELY THAT THIS ISSUE SHOULD RECUR AND RESULT IN SERIOUS HARM. CORRECTIVE ACTION: THIS ISSUE HAS BEEN CORRECTED IN VERSION 11. A DISCREPANCY REPORT (DR) HAS BEEN RAISED FOR CORRECTION OF THIS ISSUE IN A FUTURE MAINTENANCE RELEASE OF VERSION 10. NO ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    PLANNED SSD NOT CLEARED WHEN COPYING PLAN FROM AN UNAPPROVED PLAN. THE CUSTOMER REPORTS THAT THEY COPIED A PLAN FOR A SUBSEQUENT PHASE. DURING THE PLANNING PROCESS, THE ISOCENTER WAS MOVED INTO THE NEW COPIED PLAN. THE CALCULATED SSD WERE AUTOMATICALLY UPDATED, HOWEVER THEY NOTICED THAT DURING THE PLANNING APPROVAL PROCESS, THE DIALOGUE BOX SHOWED A DISCREPANCY BETWEEN THE CALCULATED AND PLANNED SSDS. THE PLANNED SSDS WERE NOT UPDATED ACCORDINGLY. MOREOVER, IN RT CHART, THE SSD IS NOT UPDATED AND IS SHOWING THE SSD FROM THE ORIGINAL PLAN. THE PLAN THAT WAS ORIGINALLY COPIED WAS IN 'UNAPPROVED' STATUS. THERE WAS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE SYSTEM, PLANNING, RADIATION THERAPY TREAT MUJ VARIAN MEDICAL SYSTEMS, FINLAND OY H48

    Patients

    Seq Age Sex Outcome Treatment
    1