BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2090527 · Received April 19, 2011

    Report

    Report Number
    2916710-2011-00034
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 6, 2009
    Report Date
    March 22, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE "MV IMAGES HAVE WRONG DATE STAMP WHEN A COMMON CLINICAL WORKFLOW IS USED" IS A KNOWN ISSUE AND HAS BEEN TRACKED AND TRENDED SINCE 03/2009. CONSIDERED BY VARIAN AS NOT TO BE A SIGNIFICANT SAFETY RISK, A WORKAROUND WAS IDENTIFIED FOR THIS ISSUE, SUCH THAT THE CUSTOMER SHOULD CLOSE THE PT INSTEAD OF PRESSING 'SAVE IMAGE'. WHEN PT IS CLOSED, IMAGE RECORDS ARE SAVED PRIOR TO THE IMAGE SAVE AND THEREFORE, THE IMAGE DAMEON WOULD NOT CHANGE THE CREATION DATE. IN 2009, A DISCREPANCY REPORT (DR) WAS LOGGED AND THE ISSUE FIXED IN THE VERSION 8.6.17 PRODUCTION RELEASE. THE ISSUE STILL EXISTS FOR CUSTOMERS WITH VERSIONS < 8.6.17. AS A RESULT OF THE MOST RECENT COMPLAINT RECEIVED 02/23/2011, VARIAN PERFORMED A NEW RISK HAZARD ANALYSIS (RHA), IN WHICH THE LATEST COMPLAINT AND TRENDING INFO WERE CONSIDERED AND EVALUATED. AS A RESULT OF THIS RHA, VARIAN DETERMINED ON 03/22/2011, THAT THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS HARM, AND HAS ISSUED A CAPA TO FURTHER ADDRESS THIS ISSUE FOR CUSTOMERS WITH VERSIONS <8.6.17. THIS REPORT IS A RESULT OF VARIAN'S RETROSPECTIVE REVIEW AND TRENDING DATA. ALL CORRECTIVE ACTION RELATED TO THIS MALFUNCTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEIR IMRT PROTOCOL IS: ON DAY ONE, A V-SIM, TAKE MV IMAGES WITH NO TREATMENT, 2ND DAY IS A V-SIM, TAKE MV IMAGES AND DO A TREATMENT, 3RD, 4TH AND 5TH DAY, THEY DO V-SIM, TAKE MV IMAGES AND TREAT. ON THE FIRST DAY THE MV IMAGES SAVE TO OLR AS THEY SHOULD. ON THE 2ND DAY, THE MV IMAGES ARE SAVING TO OLR BUT WITH THE SAME DATE AS THE FIRST DAYS IMAGES, THEREFORE, IT IS HARD TO TELL THE DIFFERENCE OF WHICH SET OF IMAGES WERE ACTUALLY TAKEN ON THE 2ND DAY. THE IMAGES TAKEN ON THE 3RD, 4TH AND 5TH DAY SAVE TO OLR CORRECTLY. IF YOU LOOK IN RTC, THE DATE OF IMAGES TAKEN ARE ALSO CORRECT. WHEN LOOKING IN PT VIEWING OF THESE IMAGES, THE DATES ARE INCORRECT THERE, JUST AS THEY ARE IN OLR. THIS IS HAPPENING ON MULTIPLE PTS. THERE WAS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONCOLOGY NONE IYE VARIAN MEDICAL SYSTEMS, INC. HRO

    Patients

    Seq Age Sex Outcome Treatment
    1