BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONC MGT SYS

    MDR report key: 1883350 · Received October 21, 2010

    Report

    Report Number
    2916710-2010-00121
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 2, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL REPORT, VARIAN'S MEDICAL ADVISOR HAS IDENTIFIED THAT 200 CGY PER DAY TO A TOTAL OF 5000 CGY FOR 3-DAYS. THE WEDGE WAS LEFT OUT ON THE AP FIELD SO THERE MAY HAVE BEEN A SLIGHT DIFFERENCE IN DOSE DISTRIBUTION AND THEREFORE AN OVERDOSE CORRESPONDING TO WHERE THE THICKER PART OF THE WEDGE SHOULD HAVE BEEN. THIS WAS 60 CGY PER DAY OUT OF 200 CGY AND THE MAXIMUM OVERDOSE WOULD BE 3.6% PER OF THE TOTAL DOSE. THIS IS NOT BELIEVED TO BE A SIGNIFICANT RISK TO PT. THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION IN THE DEVICE WHICH, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PLAN WAS IMPORTED AND FIELD A WAS SUPPOSED TO HAVE A WEDGE ATTACHED TO IT, HOWEVER, THEY JUST REALIZED, AFTER 3 FRACTIONS (FIELD A = 107 MU & 60 CGY), THAT THIS FIELD DOES NOT HAVE A WEDGE. EXTRA PLAN DATA: TOTAL DOSE = 5000 CGY. DOSE PER FRACTION = 200 CGY. TOTAL FRACTIONATION = 25 FRACTIONS. CUSTOMER STATES THAT NO ERROR MESSAGE WAS SEEN WHEN IMPORTING IN THE PLAN. DUE TO THE MISSING WEDGE, THERE WAS VARIANCE IN THE PT'S RADIATION PRESCRIPTION. NOTE: CUSTOMER IS AWARE THAT THIS COULD HAVE BEEN USE ERROR. HE WILL BRING THIS TO THE DOCTOR'S ATTENTION TO EVALUATE BEFORE THE 4TH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONC MGT SYS ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS HRO2770 - ARIARO

    Patients

    Seq Age Sex Outcome Treatment
    1