BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONE MGT SYS

    MDR report key: 1657894 · Received April 6, 2010

    Report

    Report Number
    2916710-2010-00033
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 10, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K001643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGATION THAT THE CIAO OUTLINE FROM ECLIPSE OR RTCHART IS INCORRECT HAS BEEN CONFIRMED. BASED ON THE CUSTOMER'S REPORT, THERE IS A POTENTIAL FOR MISADMINISTRATION WHEN USING THE INCORRECT CIAO SHAPE FOR MATCHING TREATMENT FIELDS USING THE CIAO BORDER. USING THE CIAO AS A BEAM ALIGNMENT TOOL FOR MATCHING FIELDS IS NOT AN INDICATED USE FOR THIS FEATURE. VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, IN THIS USE EXAMPLE, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE HAZARD ASSESSMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CIAO (COMPLETE IRRADIATED AREA OUTLINE) IN RT CHART (RTC) / ECLIPSE DID NOT MATCH THE CIAO IN OFFLINE REVIEW (OLR). ON DAY ONE AND DAY TWO WHEN THERAPIST SET UP THE CIAO, THEY OBSERVED ONE CIAO THAT HAD A MEDIAL BORDER THAT WAS STRAIGHT REPRESENTED BY THE CIAO IN RT CHART. ON DAY ONE, THEY IMAGED THE CIAO (BEFORE PLANNED FIELD) AND THE ACQUIRED CIAO IN OLR DID NOT MATCH THE PLANNED CIAO ON THE DRR IN OLR. THE CIAO IN RTC WAS MATCHING THE ACQUIRED CIAO. THE THERAPIST DREW THE CIAO MATCH LINE ON PT SKIN. (THIS LINE WAS THE CIAO IN RTC). HOWEVER, FROM DAY THREE AND ON, THEY HAVE BEEN SEEING A DIFFERENT CIAO WHEN SETTING UP THE IMAGE TEMPLATE AT THE TREATMENT CONSOLE. THEY WERE SEEING THE MLC LEAVES ON THE MEDIAL BORDER REPRESENTING THE CIAO IN OLR. THE THERAPIST COULD NOT IMAGE THE CIAO AS THE IMAGER WAS NOT FUNCTIONING. THERAPIST QUESTIONED PHYSICS AND DOSIMETRY, AS SHE WAS NOT SURE WHERE SHE SHOULD BE MATCHING THE ELECTRON FIELD. NO SERIOUS INJURY TO THE PT WAS REPORTED, AS THE DISCREPANCY WAS NOTICED PRIOR TO TREATMENT OF THE MATCHED FIELD, AND NO FURTHER PT DATA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONE MGT SYS ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS HIT

    Patients

    Seq Age Sex Outcome Treatment
    1