BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2192557 · Received July 1, 2011

    Report

    Report Number
    3003793371-2011-00030
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS FINLAND OY
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGATION HAS BEEN CONFIRMED: PLANNED SSD NOT CLEARED WHEN COPYING PLAN FROM AN UNAPPROVED PLAN. THIS ISSUE HAS BEEN PREVIOUSLY INVESTIGATED AND REPORTED. 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 UNAPPROVED PLAN. ROOT CAUSE: DESIGN DEFICIENCY - THERE WAS NO SYSTEM REQUIREMENT IN PLACE TO ADDRESS THIS ISSUE. VARIAN HAS DETERMINED THAT IT IS IMPROBABLY/EXTREMELY UNLIKELY THAT THIS ISSUE SHOULD RECUR AND RESULT IN SERIOUS HARM. EVEN THOUGH "PLANNING SSD" FOR THE FIELDS CONTAINS THE PREVIOUS "PLANNING SSD" VALUE, UPON INITIATING PLANNING APPROVAL, "PLANNING SSD" FOR THE FIELDS CONTAIN THE PREVIOUS PLANNING SSD, BUT NOW THE "OK" BUTTON IS NOT PRESELECTED AND IT IS ORANGE TO DRAW USER'S ATTENTION. USER MUST SELECT THE "OK" TO AGREE. INDEPENDENT MU CALCULATION (BEFORE TREATMENT) SHOULD DETECT THIS FAILURE MODE. 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. A CUSTOMER TECHNICAL BULLETIN (CTB) WILL BE ISSUED FOR CUSTOMERS OF VERSIONS 8.9 AND 10. NO ADD'L F/U 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 THAT WAS PREVIOUSLY APPROVED AND CHANGED THE BEAM PROPERTIES. WHEN THE CUSTOMER WENT TO APPROVE THE PASTED PLAN, THE PLANNED AND ACTUAL SSD DID NOT MATCH. CUSTOMER CALLED TO ENSURE THAT THEY COULD CHANGE THE SSD TO MATCH. THERE WAS NO SERIOUS INJURY REPORTED 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