BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLINAC 21 EX

    MDR report key: 787084 · Received November 22, 2006

    Report

    Report Number
    2916710-2006-00036
    Event Type
    Death
    Date Received
    November 22, 2006
    Date of Event
    September 15, 2006
    Report Date
    October 24, 2006
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K904364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DID NOT OCCUR DUE TO ANY MALFUNCTION OF THE EQUIPMENT INVOLVED IN THE TREATMENT. THE CUSTOMER ADMITTED TO USE ERROR BY FAILING TO ATTACH THE COLLIMATOR CONE TO THE CLINAC, WHICH RESULTED IN RADIATION OVER EXPOSURE. NO ADDITIONAL SUPPLEMENTS TO THIS MDR ARE EXPECTED, UNLESS NEW INFORMATION INDICATES IT IS NECESSARY.

    Description of Event or Problem · 1

    VARIAN MEDICAL SYSTEMS RECEIVED A REPORT INVOLVING A PATIENT DEATH. THE CUSTOMER STATED, A FEMALE PATIENT, WITH A CASE OF STOMACH CANCER THAT HAD METASTASIZED TO THE BRAIN WAS EXPOSED TO AN OVER-DOSE OF RADIATION DURING STEREOTACTIC RADIOSURGERY (SRS) TREATMENT. THIS WAS DUE TO THE RADIOLOGIST FAILING TO ATTACH THE ACCESSORY CONE MOUNT TO THE CLINAC. THE OVER-DOSE WAS ESTIMATED TO BE 20-30GY. THE HOSPITAL HAS TAKEN THE POSITION THAT THERE IS NO CAUSE AND EFFECT DUE TO THE RADIATION OVER-DOSE. THE CAUSE OF DEATH WAS STATED AS, "CESSATION OF BREATHING DUE TO COMPLICATIONS FROM LUNG CANCER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 21 EX LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS 27 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death