BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16452870 · Received February 28, 2023

    Report

    Report Number
    3010034862-2023-00004
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    April 25, 2022
    Report Date
    March 12, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K211867
    Removal / Correction Number
    RES 90498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. AN ISSUE WITH PROPAGATION OF TREATMENT COURSE INFORMATION FROM RAYSTATION WITH RAYTREAT TO RAYCARE HAS BEEN IDENTIFIED. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON THE INCOMPLETE TREATMENT COURSE INFORMATION (SCENARIOS 1 AND 4 MENTIONED IN FIELD B.5.), THIS COULD LEAD TO DELIVERING MORE OR LESS FRACTIONS THAN INTENDED. THIS COULD LEAD TO OVER-OR UNDER-DOSE, THE MAGNITUDE OF WHICH WILL DEPEND ON THE NUMBER OF FRACTIONS. IF INCORRECT SETUP INFORMATION IS USED (SCENARIO 3), INCORRECT PATIENT SETUP MAY OCCUR, POTENTIALLY LEADING TO OVER-DOSE IN HEALTHY TISSUE AND/OR UNDER-DOSE TO TARGET.

    Description of Event or Problem · 0

    AN ISSUE WITH PROPAGATION OF TREATMENT COURSE INFORMATION FROM RAYSTATION WITH RAYTREAT TO RAYCARE HAS BEEN IDENTIFIED. DURING SOME WORKFLOWS, INFORMATION MAY NOT BE PROPAGATED TO RAYCARE. WORKFLOWS WHERE SAFETY RELATED INFORMATION MAY NOT BE PROPAGATED ARE: WHEN TREATMENT HAS BEEN PERFORMED AND IS TO BE RECORDED, EITHER ONLINE (NORMAL) OR OFFLINE THROUGH MANUAL RECORDING OR OFFLINE IMPORT OF TREATMENT RECORD(S), RAYCARE MIGHT NOT RECEIVE INFORMATION ABOUT THE PERFORMED TREATMENT; ADDING A CONTINUATION SESSION IN RAYSTATION MIGHT NOT BE REPORTED TO RAYCARE. AS AN ADDITIONAL CONSEQUENCE, RAYCARE MAY CRASH REPEATEDLY IN THIS SCENARIO; PLAN ASSIGNMENT IN RAYSTATION MAY NOT BE UPDATED IN RAYCARE; FRACTIONS ADDED TO END OF TREATMENT COURSE IN RAYSTATION MAY NOT BE PROPAGATED TO RAYCARE.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSA: MDR 3010034862-2023-00004 99333 RS RT RCMD TREATMENT COURSE INFORMATION NOT SYNCED WITH RC. ONE CUSTOMER HAS REPORTED THREE CASES WHERE TREATMENT COURSE INFORMATION HAS NOT BEEN CORRECTLY PROPAGATED FROM RAYSTATION TO RAYCARE WHEN USING RAYTREAT. THE SAME ISSUE COULD POTENTIALLY OCCUR WHEN USING RAYCOMMAND. DURING SOME WORKFLOWS, INFORMATION MAY NOT BE PROPAGATED TO RAYCARE. WORKFLOWS WHERE SAFETY RELATED INFORMATION MAY NOT BE PROPAGATED ARE: 1. WHEN TREATMENT HAS BEEN PERFORMED AND IS TO BE RECORDED, EITHER ONLINE (NORMAL) OR OFFLINE THROUGH MANUAL RECORDING OR OFFLINE IMPORT OF TREATMENT RECORD(S), RAYCARE MIGHT NOT RECEIVE INFORMATION ABOUT THE PERFORMED TREATMENT. 2. ADDING A CONTINUATION SESSION IN RAYSTATION MIGHT NOT BE REPORTED TO RAYCARE. AS AN ADDITIONAL CONSEQUENCE, RAYCARE MAY CRASH REPEATEDLY IN THIS SCENARIO. 3. PLAN ASSIGNMENT IN RAYSTATION MAY NOT BE UPDATED IN RAYCARE. 4. FRACTIONS ADDED TO END OF TREATMENT COURSE IN RAYSTATION MAY NOT BE PROPAGATED TO RAYCARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560876 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 9B SP1, 10A SP1, 11A SP1, 11A SP2.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown