BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIAN

    MDR report key: 1898477 · Received November 8, 2010

    Report

    Report Number
    MW5018144
    Event Type
    Injury
    Date Received
    November 8, 2010
    Report Date
    November 8, 2010
    Product Code
    IYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A STEREOTACTIC RADIOSURGERY PT AT (B)(6) RADIATION ONCOLOGY IN (B)(6) WAS GIVEN TREATMENT WITHOUT THE CONE DEVICE THAT LIMITS THE RADIATION BEAM TO A RELATIVELY SMALL -APPROXIMATELY 14 TO 20MM- CIRCULAR BEAM. THE PT RECEIVED A PORTION OF HER TREATMENT WITH A 5CM BY 5CM SQUARE BEAM BEFORE THE ERROR WAS RECOGNIZED, AND THE TREATMENT STOPPED. THAT KIND OF ERROR COULD EASILY RESULT IN THE PT'S DEATH. THE MEDICAL DEVICE USED FOR THE STEREOTACTIC RADIOSURGERY TREATMENT WAS SOLD BY VARIAN. THE DEVICE WAS ORIGINALLY DEVELOPED BY (B)(4), A COMPANY THAT VARIAN NOW OWNS. THE DEVICE LACKS A SAFETY INTERLOCK WHICH WOULD PREVENT TREATMENT WITHOUT THE CIRCULAR BEAM LIMITING CONE BEING IN PLACE. THIS IS A GLARING DEFICIENCY IN THE PRODUCT DESIGN. VARIAN LINEAR ACCELERATORS HAVE MANY INTERLOCK SAFETY SYSTEMS. IT IS VERY ODD, AND IN MY OPINION IRRESPONSIBLE, THAT VARIAN WOULD MARKET A SYSTEM WITHOUT A BASIC, SIMPLE SAFETY INTERLOCK WHEN THE SYSTEM IS DESIGNED TO GIVE A VERY HIGH RADIATION DOSE IN ONE TREATMENT. THIS ERROR OCCURRED SEVERAL YRS AGO. (B)(6) RADIATION ONCOLOGY HAS NOT TREATED VERY MANY STEREOTACTIC PTS, SO THE PT'S NAME SHOULD BE RELATIVELY EASY TO FIND. THE MGMT AT (B)(6) HAS ACTIVELY PURSUED A COURSE OF HIDING THIS EVENT FROM THE (B)(6) DEPT OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN LINEAR ACCELERATOR IYE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening