BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIS

    MDR report key: 491575 · Received October 24, 2003

    Report

    Report Number
    2914292-2003-00009
    Event Type
    Injury
    Date Received
    October 24, 2003
    Date of Event
    August 6, 2003
    Report Date
    October 24, 2003
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS MISTREATED IN 36 OUT OF 42 FRACTIONS BECAUSE ONE OF THE FIELDS (LPO) DIDN'T HAVE THE DMLC ATTACHED TO IT IN VARIS FROM THE FIRST DAY OF TREATMENT. THE FIELD WAS TREATED WITH IMRT MU BUT WAS AN OPEN FIELD. PRIMARY REFERENCE POINT RECEIVED 2.38GY/FRAC INSTEAD OF THE PLANNED AMOUNT OF 1.8GY/FRAC. AUTUAL DELIVERED DOSE DISTRIBUTION WAS DIFFERENT FROM THE ONE ACCEPTED AT THE TIME OF PLAN APPROVAL. DOSE PER "PRACTION" WAS 32.2% HIGHER THAN THE PLANNED ONE, TOTAL DOSE DELIVERED EXCEEDED THE PRESCRIPTION BY 10%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIS SOFWARE ASSISTING RADIATION TREATMENT PLANNING MUJ VARIAN MEDICAL SYSTEMS 85 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR