BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIA

    MDR report key: 1651338 · Received April 1, 2010

    Report

    Report Number
    2916710-2010-00026
    Event Type
    Injury
    Date Received
    April 1, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 5, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DATA PROVIDED BY THE CUSTOMER INDICATES THAT THIS EVENT OCCURRED AS A RESULT OF USER ERROR AND NOT DEVICE MALFUNCTION. ALTHOUGH THE UNPLANNED DOSES REPORTED BY THE SITE WERE WITHIN ESTABLISHED TOLERANCES, THE OPINION OF VARIAN'S MEDICAL PROFESSIONAL IS THAT THERE IS SOME POSSIBILITY THAT THIS PATIENT WAS INJURED, BECAUSE THE AMOUNT OF DOSE WAS HIGHER THAN THAT PLANNED. VARIAN HAS THEREFORE, DETERMINED THAT AN MDR IS APPROPRIATE. NO FURTHER FOLLOW-UP TO THIS MDR IS EXPECTED. (B) (4)

    Description of Event or Problem · 1

    THIS INCIDENT INVOLVES A TREATMENT PLAN CREATED IN A THIRD PARTY TREATMENT PLANNING SYSTEM CALLED XIO, MANUFACTURED BY ELEKTA, WHICH WAS THEN IMPORTED INTO VARIAN'S ARIA ONCOLOGY INFORMATION SYSTEM AND SUBSEQUENTLY DELIVERED BY A VARIAN MEDICAL LINEAR ACCELERATOR. AFTER DELIVERING 12 OF 25 FRACTIONS OF AN ORAL CAVITY TREATMENT PLAN, THE THERAPIST AT THE ACCELERATOR CONSOLE NOTICED THAT MULTI-LEAF COLLIMATOR INFORMATION WAS NOT PRESENT FOR 2 OF 14 TREATMENT FIELDS. THESE 2 FIELDS EXPOSED SOME PORTIONS OF THE ORAL CAVITY AND NECK TO UNPLANNED RADIATION DOSES. THE SITE HAS REPORTED THAT THE UNPLANNED DOSES ARE WITHIN ACCEPTED TOLERANCES FOR THE AFFECTED ORGANS. NO FURTHER INFORMATION ON THE PATIENT OR HIS OR HER TREATMENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA MEDICAL CHARGED-PARTICLE RAD. THERAPY IYE VARIAN MEDICAL SYSTEMS HIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other