BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC, CL-IX

    MDR report key: 1407740 · Received June 26, 2009

    Report

    Report Number
    2916710-2009-00023
    Event Type
    Injury
    Date Received
    June 26, 2009
    Date of Event
    May 28, 2009
    Report Date
    June 3, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DID NOT OCCUR DUE TO ANY MALFUNCTION OF THE EQUIPMENT INVOLVED IN THE TREATMENT. THE DETAILS OF THE EVENT ARE FROM USER COMMUNICATION. THE PATIENT PRESCRIPTION, WHICH WAS CREATED USING VARIAN'S FASTPLAN TREATMENT PLANNING SYSTEM INCLUDED THE DESCRIPTION OF THE TREATMENT CONE, AND A CLINAC COLLIMATOR SETTING (WHICH IS LIMITED IN FASTPLAN TO A MAXIMUM OF 5 CM BY 5 CM). THE SITE USES A RECORD AND VERIFY SYSTEM FROM IMPAC (ELEKTA). THERE IS NO AUTOMATIC PLAN TRANSFER FROM FASTPLAN TO IMPAC. THE CUSTOMER ADMITTED TO USE ERROR BY FAILING TO SET THE CORRECT COLLIMATOR SETTING WHEN TRANSCRIBING THE PRESCRIPTION TO THE IMPAC SYSTEM, WHICH THEN RESULTED IN THE RADIATION OVER EXPOSURE. FURTHER ACTIONS WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. NOTE THAT THE INITIAL REPORTER DID REPORT THIS RADIATION INCIDENT TO THE APPROPRIATE AUTHORITIES, AND VARIAN HAS ALSO BEEN IN CONTACT WITH THE STATE. NO ADDITIONAL SUPPLEMENTS TO THIS MDR ARE EXPECTED, UNLESS NEW INFORMATION INDICATES IT IS NECESSARY.

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS BEING TREATED FOR MENINGIOMA (NON MALIGNANT) IN THE BRAIN APEX AREA WITH 13 ARC FIELDS TO MULTIPLE ISOCENTERS, 13 GY TO TARGET IN SINGLE FRACTION. SRS CONES WERE USED FOR ALL FIELDS. WHEN THE PRESCRIPTION WAS ENTERED INTO THE IMPAC R&V SYSTEM, THE DOSIMETRIST ENTERED A FIELD SIZE OF 10 X 10 - WHEREAS 5 X 5 IS THE DESIRED FIELD SIZE WHEN SRS CONES ARE USED. THE SRS CONE BLOCKS A 10 CM DIAMETER CIRCLE, SO THE RADIATION WAS ABLE TO 'FLASH' AROUND THE CONE IN THE CORNERS OF THE 10 X 10 FIELD. CALCULATIONS ARE IMPRECISE AT THIS TIME, BUT INDICATE THAT ABOUT 500 CGY WAS DELIVERED OVER A FAIRLY EXTENSIVE VOLUME OF HEALTHY BRAIN TISSUE (OPTIC NERVE, BRAIN STEM NOT INVOLVED). THE CUSTOMER REALIZES IT WAS A USE ERROR, BUT IS FRUSTRATED THAT VARIAN DID NOT PROVIDE AN INTERLOCK THAT WOULD PREVENT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC, CL-IX LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS H29 CL-IXT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other