BEUDAMED
    FDA Adverse Event Other Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 725492 · Received June 6, 2006

    Report

    Report Number
    2916710-2006-00011
    Event Type
    Other
    Date Received
    June 6, 2006
    Date of Event
    April 5, 2005
    Report Date
    October 5, 2005
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN HELP DESK PERSONNEL CONNECTED REMOTELY TO THE CUSTOMER'S COMPUTER SYSTEM TO LOOK AT THE PATIENT HISTORY. THIS CONFIRMED THAT THE THERAPIST DID OVER RIDE THE FIELD SIZE FOR THE TREATMENT IN QUESTION. THIS ISSUE OCCURRED DUE TO USER ERROR. AT THE TIME VARIAN RECEIVED THE ORIGINAL REPORT, VARIAN ANALYZED IT AND CONCLUDED THAT THERE HAD BEEN NO SERIOUS INJURY AS DEFINED IN 21 CFR 803.3 (Z) (BB) AND WE ALSO CONSIDERED THE RADIATION THERAPY MEDICAL COMMUNITY'S UNDERSTANDING OF SERIOUS INJURY FOR RADIATION OVER DOSE OR UNDER DOSE AMONGST RADIATION THERAPY PROFESSIONALS. FOR THAT REASON WE DID NOT SUBMIT AN MDR PREVIOUSLY. HOWEVER VARIAN IS NOW REPORTING THIS INCIDENT AS AN MDR BASED UPON SPECIFIC DIRECTION FROM OUR FDA INVESTIGATOR AS TO THE FDA'S INTERPRETATION OF "SERIOUS INJURY" IN THE CONTEXT OF RADIATION THERAPY.

    Description of Event or Problem · 1

    USER INADVERTANTLY OVER RODE THE FIELD SIZE WHEN ATTEMPTING TO OVER RIDE THE GANTRY. FIELD SIZE SHOULD HAVE BEEN X1=7.0 AND X2=8.5 AND INSTEAD WAS X1=8.5 AND X2=7.0. CUSTOMER DISCOVERED THIS ISSUE WHEN LOOKING AT THE PATIENT HISTORY. EXACT RADIATION EXPOSURE/DOSAGE INFORMATION WAS NOT PROVIDED BY CUSTOMER, HOWEVER, THIS PATIENT WAS TREATED WITH AN INCORRECT FIELD SIZE FOR ONLY ONE FIELD ON ONE DAY WITH A DIFFERENCE OF 1.5CM ON ONE AXIS OF THE TREATMENT FIELD. PHYSICIST ACKNOWLEDGED THAT THIS WAS A RESULT OF USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE LINEAR ACCELERATOR SOFTWARE IYE VARIAN MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other