BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLETRON ONCENTRA MASTERPLAN HDR V3

    MDR report key: 1633628 · Received March 16, 2010

    Report

    Report Number
    1633628
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    February 10, 2010
    Report Date
    March 15, 2010
    Manufacturer
    NUCLETRON CORP
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE TREATMENT UNIT WAS THE NUCLETRON HDR V3. THE EVENT WAS AN UNDER DOSE FOR 2 FRACTIONS (BID). THE DOSE PRESCRIPTION PER FRACTION WAS 4 GY. THE DOSE DELIVERED PER FRACTION WAS 0.4 GY. THE TOTAL UNDER DOSE WAS 7.2 GY. THE EVENT WAS CAUSED BY A SOFTWARE BUG THAT UPDATED THE ISODOSE LINES UPON CHANGING THE NORMALIZATION, BUT DID NOT UPDATE THE DWELL TIMES. THIS WAS THE FIRST TIME WE HAD USED THIS PARTICULAR NORMALIZATION METHOD WITH THIS PLANNING SYSTEM SO OTHER PATIENTS WOULD NOT HAVE BEEN AFFECTED BY THIS BUG. THE EVENT WAS DISCOVERED DURING OUR QA CHECK FOR THE PATIENT. PATIENT QA INVOLVES RELOADING THE PATIENT'S PLAN EACH DAY AND RECALCULATING THE DWELL TIMES. THE DWELL TIMES WERE UPDATED AFTER THE PLAN WAS RELOADED AND THE ERROR WAS DISCOVERED. THE ATTENDING WAS NOTIFIED AND THE PRESCRIPTION MODIFIED TO ACCOUNT FOR THE DEFICIT. NUCLETRON WAS CONTACTED TO REPORT THE SOFTWARE BUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLETRON ONCENTRA MASTERPLAN HDR V3 SOFTWARE, RADIATION TREATMENT PLANNING, HDR MUJ NUCLETRON CORP HDR V3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES