BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 1882717 · Received October 13, 2010

    Report

    Report Number
    3003793371-2008-00011
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    December 18, 2008
    Report Date
    December 18, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER BEAM DATA (6X) AND PLANS WERE USED FOR THE INVESTIGATION. ECLIPSE VERSION 8.6.15 FOR BOTH CLIENT AND AAA WAS USED. THE BEAM DATA PROFILES WERE ALSO COMPARED TO GB DATA. THE SECOND SOURCE INTENSITY VALUE, WHICH SEEMED TO BE QUITE HIGH WAS STUDIED AND COMPARED TO THE DATA SETS AVAILABLE WITH AAA RESEARCH TEAM. PLANS WERE RECALCULATED AFTER SPLIT AND DOSE FOR DIFFERENT STRUCTURES WERE COMPARED TO THE ORIGINAL NON SPLIT PLAN. THE INVESTIGATION CONFIRMS DEVICE MALFUNCTION DUE TO SOFTWARE DESIGN LIMITATION THAT RESULT IN DOSIMETRIC/CALCULATION ERRORS IN TREATMENT PLANNING. SPLIT FIELD IMRT PLANS CAN DELIVER HIGHER THAN INTENDED DOSES, COMPARED TO THE APPROVED TREATMENT PLANS BEFORE THE MULTI-CARRIAGE SPLIT. LARGE IMRT FIELDS THAT MUST BE DIVIDED INTO SMALLER FIELDS FOR DELIVERY HAVE BEEN FOUND TO DELIVER HIGHER DOSES THAN PLANNED, WHEN THE DIVIDED FIELDS ARE RECALCULATED. INVESTIGATION HAS FOUND THAT THE HIGHER THAN INTENDED DOSES ARE MORE PRONOUNCED WITH A 90 DEGREES COLLIMATOR POSITION WITH THE MLC LEAVES IN THE SUPERIOR - INFERIOR DIRECTION. DOSE DIFFERENCES, GREATER THAN 10%, WERE FOUND AFTER RE-CALCULATION OF THESE SPLIT FIELD IMRT PLANS. WITHOUT PRE-TREATMENT PLAN QA, THE DOSE DIFFERENCE COULD GO UNDETECTED FOR AN ENTIRE COURSE OF TREATMENT. HIGHER THAN INTENDED TOTAL DOSE TO TARGETS AND CRITICAL STRUCTURES COULD LEAD TO INCREASED TOXICITY AND SERIOUS INJURY REQUIRING MEDICAL INTERVENTION. IN THIS CASE THERE WAS NO SERIOUS INJURY REPORTED. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO VARIAN: IN CASE OF SPLITTED IMRT FIELDS, THE AAA ALGORITHM (8.6.03 AND 8.2.23) IS NOT TAKING INTO ACCOUNT THE JAW SETTING OF THE SECOND (AND THIRD) CARRIAGE POSITION. THIS WILL LEAD TO WRONG CALCULATED DOSE OF THE SECOND (AND THIRD) SUBFIELD. DOSE COMPARISONS BETWEEN THE MANUAL SUM OF THE SUBFIELDS AND THE ECLIPSE CALCULATION ARE SHOWING DOSE DISCREPANCIES IN THE RANGE OF 2-3%. THIS ERRORS COULD BE VERIFIED AS WELL WITH MEASUREMENTS. NO PT INJURY REPORTED AND NO PT DATA PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEMS MUJ VARIAN MEDICAL SYSTEMS H48

    Patients

    Seq Age Sex Outcome Treatment
    1