BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE

    MDR report key: 2354669 · Received November 21, 2011

    Report

    Report Number
    3003793371-2011-00046
    Event Type
    Injury
    Date Received
    November 21, 2011
    Date of Event
    November 11, 2011
    Report Date
    November 11, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K073020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL REPORT VARIAN'S MEDICAL ADVISOR DETERMINED THAT THE PT BEING TREATED TO THE BREAST, RECEIVED 4-TREATMENTS OUTSIDE PLANNED TREATMENT VOLUME BECAUSE OF WRONG JAW SETTINGS IN A HALF BEAM TECHNIQUE. THE AREAS WHICH RECEIVED THIS ADD'L DOSE WERE UPPER LUNG, HUMERUS, BRACHIAL PLEXUS AND AXILLA. THIS DOSE OF 800CGY (200X4) IS UNLIKELY TO CAUSE SERIOUS ACUTE INJURY, BUT IT IS UNK ABOUT THE POSSIBILITY OF INJURY IN THE FUTURE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    VARIAN RECEIVED A REPORT INVOLVING PT MISADMINISTRATION DURING TREATMENT. THE PT RECEIVED RADIATION OUTSIDE THE PLANNED TARGET AREA. THE PHYSICIAN INTENDS TO MODIFY THE PT'S TREATMENT PLAN OR THERAPY AS A RESULT OF THE EVENT. NO OTHER INFORMATION WAS REPORTED ON THE PT STATUS. THE REPORT INDICATED THAT THE VARIAN ECLIPSE TREATMENT PLANNING SYSTEM AND SIEMENS ONCOR WITH 160-MULTILEAF COLLIMATOR WERE BEING USED AT THE TIME OF THE INCIDENT. THE SIEMENS ONCOR WITH 160-MULTILEAF COLLIMATOR IS NOT MANUFACTURED BY VARIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS H48

    Patients

    Seq Age Sex Outcome Treatment
    1