BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE TREATMENT PLANNING SYSTEM

    MDR report key: 2502135 · Received March 2, 2012

    Report

    Report Number
    3003793371-2012-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 9, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    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. THE MALFUNCTION WAS PREVIOUSLY REPORTED ON MEDWATCH # 3003793371-2011-00014. THE ENERGY SHOWN OR SELECTED BY THE TREATMENT PLANNER IN THE FIELDS TAB OF EXTERNAL BEAM PLANNING AND IN THE GENERAL TAB OF FIELD PROPERTIES, MAY DIFFER FROM THE VALUE ACTUALLY USED FOR DOSE CALCULATION. ROOT CAUSE: THIS ISSUE IS CAUSED BY INCORRECT HANDLING OF THE ENERGY MODE OBJECT WITHIN THE MEMORY CACHE SYSTEM USED BY ECLIPSE EXTERNAL BEAM PLANNING VERSION 10. WHEN THE USER CHANGES THE FIELD ENERGY, THE MEMORY CACHE ANOMALY MAY RESULT IN THE USE OF THE PREVIOUSLY SELECTED FIELD ENERGY INSTEAD OF THE INTENDED FIELD ENERGY. THIS CACHE MEMORY ISSUE MAY ARISE WHEN SWITCHING BETWEEN SOFTWARE APPLICATIONS (SUCH AS BETWEEN EXTERNAL BEAM PLANNING AND RT CHART), WHEN USING MULTIPLE SESSIONS, OR WHEN SWITCHING BETWEEN PATIENTS IN A SINGLE SESSION OF THE EXTERNAL BEAM PLANNING APPLICATION IN ECLIPSE. WHEN THIS ISSUE OCCURS, IT CAN BE IDENTIFIED BY INSPECTION OF THE DOSE LOG AND LCM LOG (LEAF-MOTION CALCULATOR LOGS ARE GENERATED FOR IMRT AND ELECTRONIC COMPENSATOR FIELDS) IN THE "ERRORS AND WARNINGS FROM LAST CALCULATION" IN THE CALCULATION TAB OF THE FIELD PROPERTIES. THE MU AND DOSE DISTRIBUTION WILL BE CORRECT FOR THE ENERGY SHOWN IN THE DOSE AND LMC CALCULATION LOGS. VARIAN CONFIRMED THAT THE CUSTOMER RECEIVED THE URGENT MEDICAL DEVICE LETTER, DATED 6/30/2011. CORRECTIVE ACTION WAS REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO FURTHER FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO VARIAN THAT THEY HAVE RUN INTO AN INSTANCE OF AN ENERGY MISMATCH. THE USER PLANNED A SINGLE FIELD ELECTRON BEAM WITH ENERGY OF 6E AND THE CALCULATION NOTES OF THE BEAM CLEARLY SHOW THAT 16E WAS USED. ACCORDING TO THE REPORT, THERE WAS NO PT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM SYSTEM, PLANNING, RAD THERAPY TREATMENT MUJ VARIAN MEDICAL SYSTEMS, INC. H48

    Patients

    Seq Age Sex Outcome Treatment
    1