BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLETRON PLATO

    MDR report key: 117572 · Received August 26, 1997

    Report

    Report Number
    117572
    Event Type
    Malfunction
    Date Received
    August 26, 1997
    Date of Event
    March 7, 1997
    Report Date
    March 13, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING TREATED FOR CHEST WALL CANCER WITH FRACTIONATED HIGH DOSE RATE (HDR) BRACHYTHERAPY. DURING COURSE OF TREATMENT, THE RADIOACTIVE SOURCE WAS ROUTINELY REPLACED IN THE HDR. THE ENTERING OF THE NEW SOURCE ACTIVITY INTO THE TREATMENT PLANNING COMPUTER INTERFACED TO THE HDR LEAD TO A CALCULATIONAL ERROR BY THE TREATMENT PLANNING COMPUTER. THIS ERROR RESULTED IN DELIVERING APPROX. TWICE THE DOSE DESIRED TO 1/2 THE AREA DESIRED FOR 1 FRACTION OF THE TREATMENT REGIME. NO ADVERSE PT EFFECT IS EXPECTED, AS THE FUTURE TREATMENT FRACTIONS WILL BE MODIFIED TO COMPENSATE FOR THE INCORRECT FRACTION DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLETRON PLATO BRACHYTHERAPY TREATMENT PLANNING SYSTEM IWB NUCLETRON CORP. PLATO *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR