BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 2150510 · Received June 23, 2011

    Report

    Report Number
    2916710-2011-00073
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VARIAN MEDICAL PROFESSIONAL REVIEW OF THIS REPORT HAS DETERMINED THE FOLLOWING: PLANNED IMRT STEREOTACTIC TREATMENT WITH MICRO MLC FOR 3 TREATMENTS IN 3 DAYS OF 4 CGY PER TREATMENT. DURING ONE TREATMENT, ONLY 8 CGY WAS GIVEN INSTEAD OF THE PLANNED 400 CGY - APPARENTLY, THE 400 CGY WAS GIVEN 2 WEEKS LATER. SINCE THE FRACTION SCHEME IS EXTREMELY IMPORTANT IN ADDITION TO THE DAILY AND TOTAL DOSE, THIS TWO WEEK DELAY COULD MAKE THE RADIATION LESS EFFECTIVE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS INFORMATION PROVIDED REASONABLY SUGGESTS THAT THE VARIAN DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE ALLOWS CUSTOMER TO SWITCH FROM MILLENNIUM MLC TO MICRO MLC WITHOUT PARKING THE MILLENNIUM MLC. A STEREOTACTIC TREATMENT WITH MICRO MLC WAS PLANNED FOR A PATIENT IN 3 DAYS; 12 GRAY IN 3 DAYS, 4 GRAY PER DAY. THE SESSION OF THE LAST DAY WAS DELIVERED WITH MILLENNIUM MLC CLOSED. DURING THE PATIENT SET UP FOR STEREOTACTIC TREATMENT, THE USERS DIDN'T SEE THE FIELD LIGHT AND THEY THOUGHT THAT THE LAMP WAS DEAD. BEFORE THE STEREOTACTIC TREATMENT, AN IMRT TREATMENT WAS DELIVERED THAT LEFT THE MILLENNIUM MLC CLOSED. THE CUSTOMER INSTALLED MICRO MLC FOR THE STEREOTACTIC TREATMENT. FOR THE TREAT APPLICATION, THEY SWITCH FROM MILLENNIUM MLC TO MICRO MLC WITHOUT PARKING THE MILLENNIUM MLC. THE SITE REPORTS THAT THE PHYSICIAN HAS PLAN TO TREAT THE PATIENT BY 400 CGY SESSIONS; BECAUSE THE MEASURED DOSE DURING THE EVENT WAS 8 CGY INSTEAD OF 400 CGY; IN FACT, IT WOULD BE TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H51

    Patients

    Seq Age Sex Outcome Treatment
    1