BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE

    MDR report key: 1674820 · Received April 30, 2010

    Report

    Report Number
    3003793371-2010-00005
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    March 31, 2010
    Report Date
    March 31, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K010975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EDIT LOGS WERE FURTHER EVALUATED AND CONFIRM THAT THE PLAN WAS "COPY AND PASTED" AS A NEW PLAN IN THE SAME COURSE. ADDITIONAL EDIT OPERATIONS WERE PERFORMED FOLLOWING THE "COPY AND PASTE" OPERATION. THE EDIT LOGS ALSO DEMONSTRATED THAT THE COLLIMATOR ROTATION FOR FIELD (F3) WAS SOMEHOW INADVERTENTLY CHANGED DURING THIS PROCESS. THE USER HAS BEEN ADVISED, AND AGREES, THAT THE INCIDENT WAS THE RESULT OF THE USE ERROR. PLANS WHICH ARE EDITED AFTER INITIAL APPROVAL REQUIRE RE-APPROVAL BEFORE BEING AVAILABLE FOR TREATMENT. THE USER IS ADVISED TO EXERCISE MORE CARE WHEN MANUALLY EDITING PLANS, TO ENSURE THAT CRITICAL PARAMETERS HAVE NOT BEEN ALTERED IN THE PROCESS, AND TO FURTHER ACCESS THIS DATA DURING THE RE-APPROVAL PROCESS. VARIAN'S PROCESS IN THE CASE OF ANY RADIATION MISTREATMENT IS TO OBTAIN A SECOND OPINION FROM A CONSULTING RADIATION ONCOLOGIST AS TO WHETHER OR NOT THE INCIDENT RESULTED IN A PROBABLE INJURY FOR THE PT - WHILE THIS REPORT INDICATES A UNDER DOSE AND THE INTENTION OF THE USER TO CORRECT THE DOSE IN SUBSEQUENT TREATMENTS, WE WERE UNABLE TO OBTAIN SUFFICIENT INFO FOR OUR RADIATION ONCOLOGIST TO CONCLUDE THAT THERE WAS NO INJURY. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT WAS UNDER DOSED APPROX <5% OF PTV (PLANNED TARGET VOLUME) WITH THE INCORRECT COLLIMATOR ROTATION OF 0 DEGREE AS OPPOSED TO 330 DEGREES. IT WAS REPORTED THAT THE IMRT (INTENSITY MODULATED RADIO THERAPY) PLAN HAD BEEN IMPORTED FROM (B) (4) (3RD PARTY TREATMENT PLANING PROVIDER) AND APPROVED. THE USER NOTICED THAT THE FIELD SIZE WAS TOO LARGE TO BE DELIVERED AT 1000 MU/MIN (MONITOR UNITS PER MINUTE - A MEASURE OF DOSE RATE) SO THE PLAN WAS COPIED WITHIN THE USER'S ECLIPSE TREATMENT PLANNING SYSTEM AND THE DOSE RATE CHANGED TO 600 MU/MIN FOR EACH FIELD AND THE PLAN WAS RECALCULATED. DURING THE GENERATION OF THE 'COPIED' PLAN FOR ONE FIELD, THE COLLIMATOR ROTATION WAS INADVERTENTLY CHANGED. THE ORIGINAL FIELD HAD A ROTATION OF 330 DEGREES AND ON THE COPIED PLAN IT NOW READS 0 DEGREE. NO FURTHER PT INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1