BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16462021 · Received March 1, 2023

    Report

    Report Number
    3007774465-2023-00007
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    September 1, 2021
    Report Date
    March 20, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K211867
    Removal / Correction Number
    RES 89800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. THE ISSUE CONCERNS ALL RAYSTATION/RAYPLAN VERSIONS 4 - 11A, INCLUDING SERVICE PACKS. IN THE EVENT THAT AN INAPPROPRIATE TREATMENT PLAN WAS APPROVED FOR TREATMENT DUE TO THIS ERROR, THIS COULD RESULT IN A LOCAL OVER DOSAGE IN A RISK ORGAN OR LOCAL UNDER DOSAGE IN A TARGET. THE CLINICAL CONSEQUENCES DEPEND ON THE EXACT PLAN SETUP AND THE ANATOMY OF EACH INDIVIDUAL PATIENT AND THUS CANNOT BE GENERALLY ESTIMATED. HOWEVER, THE DENSITY ERROR AFFECTS AT THE MOST ONE ROW OF VOXELS, AND THE EFFECT ON THE OVERALL TREATMENT IS ESTIMATED TO BE FOR MOST CASES MARGINAL.

    Description of Event or Problem · 0

    NO SERIOUS EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY A USER. THE ISSUE CONCERNS THE DENSITY HANDLING OF VOXELS INTERSECTED BY BOTH THE EXTERNAL ROI AND AN ROI OF TYPE SUPPORT, FIXATION OR BOLUS IN ALL RAYSTATION/RAYPLAN VERSIONS 4 - 11A, INCLUDING SERVICE PACKS.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00007 84236 RS BOLUS DENSITY HANDLING. NO SERIOUS EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY A USER. A CUSTOMER NOTICED A DIFFERENCE IN ELECTRON DOSE DEPENDING ON WHETHER A BOLUS WAS DELINEATED INSIDE OR OUTSIDE THE PATIENT EXTERNAL CONTOUR. INVESTIGATION SHOWS THAT THERE IS A LIMITATION IN THE DISCRETIZATION OF CERTAIN REGIONS OF INTEREST (ROI). WHEN COMBINING DENSITIES FROM THE CT VALUES INSIDE THE EXTERNAL ROI WITH DENSITIES FROM AN ROI OF TYPE BOLUS, SUPPORT OR FIXATION, THE COMBINED DENSITIES MAY BE WRONG, LEADING TO SITUATIONS WHERE ACCURACY OF THE DOSE CALCULATION MAY BE LOWER THAN OTHERWISE EXPECTED. THE EFFECT WAS ALREADY KNOWN AND TO SOME EXTENT DESCRIBED IN RAYSTATION TRAINING MATERIAL, BUT NOT DESCRIBED IN THE RAYSTATION LABELING DOCUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054690 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION/RAYPLAN VERSION 4-11A, INCLUDING SERVICE PACKS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown