BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16491674 · Received March 6, 2023

    Report

    Report Number
    3010034862-2023-00013
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 2, 2021
    Report Date
    March 13, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K210645
    Removal / Correction Number
    RES 87797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. FOR PERFORMANCE REASONS, OPTIMIZATION OF PHOTON PLANS CAN BE PERFORMED USING A DOSE ENGINE THAT IS LESS ACCURATE THAN THAT USED FOR FINAL DOSE CALCULATION. THE DOSE DISTRIBUTION WILL THEN BE DISPLAYED AS "APPROXIMATE" AND IT WILL NOT BE POSSIBLE TO APPROVE OR EXPORT THE PLAN UNTIL A FINAL DOSE CALCULATION USING THE CLINICAL DOSE ENGINE HAS BEEN PERFORMED. DOSE CALCULATED WITH A DOSE ENGINE VALIDATED FOR FINAL DOSE IS DISPLAYED AS "CLINICAL". IN SOME CASES, WHEN MERGING TWO BEAMS WHERE THE FIRST BEAM HAS CLINICAL DOSE AND THE SECOND BEAM HAS APPROXIMATE DOSE, THE DOSE OF THE RESULTING BEAM WILL BE MARKED AS "CLINICAL", ALTHOUGH DOSE FOR SOME OF THE BEAM SEGMENTS IS STILL CALCULATED WITH THE APPROXIMATE DOSE ENGINE. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON AN APPROXIMATE DOSE THAT IS INCORRECTLY MARKED AS CLINICAL, THIS COULD LEAD TO THE APPROVAL OF AN INAPPROPRIATE DOSE PLAN. THIS COULD LEAD TO LOCAL OVER-DOSE IN A RISK ORGAN FROM ALLOWING TOO HIGH OF A DOSE IN THE TREATMENT PLAN OR UNDERDOSAGE TO THE TARGET.

    Description of Event or Problem · 0

    NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. THIS ISSUE WAS FOUND WITH THE MERGE BEAMS FUNCTIONALITY IN RAYSTATION/RAYPLAN. FOR SOME LINAC TYPES, MERGING CLINICAL BEAMS WITH BEAMS OF APPROXIMATE DOSE MAY LEAD TO THE APPROXIMATE DOSE ERRONEOUSLY LABELED AS CLINICAL DOSE. MERGE BEAMS CAN BE USED MANUALLY, IN SCRIPTING, OR AS PART OF THE AUTOMATED BREAST PLANNING FEATURE.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSA: MDR 3010034862-2023-00013 74977 RS MERGE BEAMS. NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. THIS ISSUE WAS FOUND WITH THE MERGE BEAMS FUNCTIONALITY IN RAYSTATION/RAYPLAN. FOR SOME LINAC TYPES, MERGING CLINICAL BEAMS WITH BEAMS OF APPROXIMATE DOSE MAY LEAD TO THE APPROXIMATE DOSE ERRONEOUSLY LABELED AS CLINICAL DOSE. MERGE BEAMS CAN BE USED MANUALLY, IN SCRIPTING, OR AS PART OF THE AUTOMATED BREAST PLANNING FEATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731156 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4.5-10B, RAYPLAN 1-10B AND SERVICE PACKS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown