BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONCENTRA MASTERPLAN

    MDR report key: 2853217 · Received June 20, 2008

    Report

    Report Number
    9611894-2008-00003
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    February 19, 2008
    Report Date
    June 19, 2008
    Manufacturer
    NUCLETRON BV
    Product Code
    MUJ
    PMA / PMN Number
    K031349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL #: 170.730. IN ONCENTRA MASTERPLAN, BEFORE PERFORMING CALCULATIONS, THE USER HAS TO DEFINE THE DOSE PRESENTATION MATRIX (3D GRID OF DOSE POINTS). BY DEFAULT, THE MATRIX ENCLOSES ALL CONTOURS OF THE CURRENT ANATOMY IN THE X AND Z DIRECTIONS (AXIAL PLANE). THE DOSE CALCULATION DOES NOT ASSUME THAT THE PT ANATOMY EXTENDS INFINITELY IN THE THIRD DIMENSION (Y). THE EXTERNAL AXIAL EXTENSION REPRESENTS AND EXTRAPOLATION OF THE PT VOLUME TO OBTAIN A BETTER APPROXIMATION OF SCATTER DOSE FROM DISTANT REGIONS. THE SYSTEM ASSUMES THE EXTENSION IS THE SAME SHAPE AS THE TOP OR BOTTOM SLICE. THE DEFAULT EXTENSION IS 0 CM SUPERIORLY AND INFERIORLY. AS WRITTEN IN THE ONLINE HELP SECTION RELATED TO THE DOSE PRESENTATION MATRIX, THE USER IS WARNED TO "ENSURE THAT THE EXTENSION LIMITS ARE CLINICALLY CORRECT; OTHERWISE THE DOSE CALCULATION CAN BECOME ERRONEOUS."

    Description of Event or Problem · 1

    A (B)(6) USER DETECTED A DISCREPANCY BETWEEN THE TREATMENT TIME CALCULATED BY ONCENTRA MASTERPLAN (OMP) AND AN INDEPENDENT CALCULATION SYSTEM. THE PT REC'D ABOUT A 12% OVERDOSE. THE TREATMENT TIME CALCULATED BY THE TREATMENT PLANNING SYSTEM WAS PLANNED FROM ONLY ONE CT SLICE W/O SPECIFYING A SUFFICIENT EXTERNAL AXIAL EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA MASTERPLAN RADIOTHERAPY TREATMENT PLANNING SYSTEM MUJ NUCLETRON BV 170.712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other