BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16492264 · Received March 6, 2023

    Report

    Report Number
    3010034862-2023-00017
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    September 10, 2020
    Report Date
    March 4, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DESIGN DEFECT (SOFTWARE IMPLEMENTATION ERROR) HAS BEEN IDENTIFIED. IF A CASE WITH PLAN, RT STRUCTURE SET AND CT SET IS IMPORTED ALL AT THE SAME TIME, THE INCORRECT REFERENCES CAN ONLY BE SET UP TO AN ROI OR POI THAT DOES NOT HAVE ANY DEFINITION ON THE CT SET. THIS MEANS THAT ROI CONTOURS OR POI COORDINATES OF THE INCORRECTLY REFERENCED ROI OR POI WOULD NOT BE DEFINED. IF THE CT SET IS IMPORTED FIRST AND SOME ROIS/POIS ARE DEFINED BEFORE IMPORTING THE RT PLAN/RT ION PLAN AND RT STRUCTURE SET, THE INCORRECTLY REFERENCED ROI/POI COULD BE DEFINED ON THE CT. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON AN INCORRECT DOSE OR AN INCORRECT PRESCRIPTON, THIS COULD LEAD TO THE APPROVAL OF AN INAPPROPRIATE DOSE PLAN. THIS COULD LEAD TO LOCAL OVER-DOSE IN A RISK ORGAN OR UNDER-DOSAGE TO THE INTENDED TARGET.

    Description of Event or Problem · 0

    NO SERIOUS ADVERSE EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. NO SERIOUS ADVERSE EVENT HAS OCCURRED, BUT AN ISSUE WITH THE DICOM IMPORT HAS BEEN IDENTIFIED. IF A REGION OF INTEREST (ROI) OR POINT OF INTEREST (POI) THAT IS REFERENCED FROM AN IMPORTED RT PLAN/RT ION PLAN IS MISSING IN THE IMPORTED RT STRUCTURE SET, THE REFERENCE MAY BECOME LINKED TO THE WRONG ROI OR POI. THE IMPORTED RT STRUCTURE SET MUST BE CORRUPT FOR THE BUG TO BE TRIGGERED, I.E. THE REFERENCED ROI/POI MUST NOT EXIST IN THE IMPORTED RT STRUCTURE SET. THE REFERENCES FROM RT PLAN/RT ION PLAN TO RT STRUCTURE SET THAT CAN BE AFFECTED BY THIS ISSUE ARE BOLUS ROI AND PRESCRIPTION ROI OR POI. MATERIAL OVERRIDE AND OTHER ROI OR POI PROPERTIES ARE NOT AFFECTED BY THIS BUG. DEPENDING ON THE APPROVAL STATUS OF THE IMPORTED PLAN AND EXISTING STRUCTURES IN RAYSTATION, THE SYSTEM MAY SOMETIMES CRASH RATHER THAN IMPORT THE FAULTY DATA.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSA: MDR 3010034862-2023-00017 66704 RS PRESCRIPTION ROI OR POI REFERENCE. NO SERIOUS ADVERSE EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. NO SERIOUS ADVERSE EVENT HAS OCCURRED, BUT AN ISSUE WITH THE DICOM IMPORT HAS BEEN IDENTIFIED. IF A REGION OF INTEREST (ROI) OR POINT OF INTEREST (POI) THAT IS REFERENCED FROM AN IMPORTED RT PLAN/RT ION PLAN IS MISSING IN THE IMPORTED RT STRUCTURE SET, THE REFERENCE MAY BECOME LINKED TO THE WRONG ROI OR POI. THE IMPORTED RT STRUCTURE SET MUST BE CORRUPT FOR THE BUG TO BE TRIGGERED, I.E. THE REFERENCED ROI/POI MUST NOT EXIST IN THE IMPORTED RT STRUCTURE SET. THE REFERENCES FROM RT PLAN/RT ION PLAN TO RT STRUCTURE SET THAT CAN BE AFFECTED BY THIS ISSUE ARE BOLUS ROI AND PRESCRIPTION ROI OR POI. MATERIAL OVERRIDE AND OTHER ROI OR POI PROPERTIES ARE NOT AFFECTED BY THIS BUG. DEPENDING ON THE APPROVAL STATUS OF THE IMPORTED PLAN AND EXISTING STRUCTURES IN RAYSTATION, THE SYSTEM MAY SOMETIMES CRASH RATHER THAN IMPORT THE FAULTY DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705951 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4-10A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown