BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLETRON PLATO

    MDR report key: 596526 · Received April 21, 2005

    Report

    Report Number
    MW1035290
    Event Type
    Injury
    Date Received
    April 21, 2005
    Date of Event
    April 7, 2005
    Report Date
    April 21, 2005
    Manufacturer
    NUCLETRON CORP. NUCLETRON B.V.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COMPLAINT HANDLING CONCLUDED THAT THE PROBELM WAS NOT A SOFTWARE ERROR AND THE PROBLEM WAS INDUCED BY THE USER. UPON REVIEW OF THE SUBMITTED INFO, THE TREATMENT PLAN PRINTOUT YIELDS A WARNING ABOUT AN INCORRECT RECONSTRUCTION OF PT POINTS (RESULTING FROM INCORRECT MAGNIFICATION FACTORS AND DISTANCES ENTERED BY THE USER) WHICH CAN LEAD TO AN INCORRECT DOSE CALCULATION. THE PROBLEM EXPERIENCED BY THE FACILITY IS ATTRIBUTED TO AN INCORRECT MAGNIFCATION FACTOR ENTERED/DETERMINED BY THE USER FROM THE PT RADIOGRAPHS USED FOR APPLICATOR RECONSTRUCTION. MAGNIFICATION INFO IS DETERMINED AND GENERATED BY THE USER FROM PT RADIOGRAPHS AND ENTERED AS TREATMENT PLANNING PARAMETERS. THE TREATMENT PLANNING SOFTWARE DOES NOT DETERMINE MAGNIFICATION.

    Description of Event or Problem · 1

    RPTR HAS A COMPUTER WORKSTATION IN RADIATION ONCOLOGY THAT IS USED TO PLAN THE DELIVERY OF HIGH DOSE RATE INTERCAVITARY RADIATION TREATMENTS. IT IS THE NUCLETRON PLATO PLANNING SYSTEM. AFTER A PLAN WAS DEVELOPED FOR A PT, THE TREATMENT TIME CALCULATED FROM THIS SYSTEM WAS 23 MINUTES. IT APPEARS THAT THE SYSTEM HAD ERRONEOUSLY MAGNIFIED THE APPLICATOR GEOMETRY BY A FACTOR OF TWO. FROM RPTR'S EXPERIENCE THEY KNEW THAT THIS TIME WAS NOT REASONABLE AND THEY THEREFORE RE-RAN THE PLAN AND FOUND THE TREATMENT TIME TO BE APPROX EIGHT MINUTES WHICH IS REASONABLE. RPTR THEN CHECKED THIS PLAN WITH AN INDEPENDENT CALCULATION AND FOUND IT ACCEPTABLE. THIS PROBLEM HAS INEXPLICABLY HAPPENED BEFORE AND RPTR WAS UNABLE TO DOCUMENT IT. THIS TIME, HOWEVER, RPTR SAVED A COPY OF THE ABERRENT PLAN. THERE WAS NO ADVERSE EFFECT UPON THE PT BUT CERTAINLY THE POTENTIAL STILL EXISTS FOR THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLETRON PLATO RADIATION THERAPY PLANNING SOFTWARE AND HARDWARE MUJ NUCLETRON CORP. NUCLETRON B.V. PLATO SOFTWARE VERSION *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention