BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16498421 · Received March 7, 2023

    Report

    Report Number
    3007774465-2023-00020
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    January 8, 2020
    Report Date
    February 28, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K190387
    Removal / Correction Number
    RES 85255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A LIMITATION IN THE SOFTWARE IMPLEMENTATION HAS BEEN IDENTIFIED. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON THE INCORRECT RAYSTATION DOSE, THIS COULD LEAD TO THE APPROVAL OF AN INAPPROPRIATE DOSE PLAN. THIS COULD LEAD TO LOCAL OVER-DDOSE IN A RISK ORGAN FROM ALLOWING TOO HIGH OF A DOSE IN THE TREATMENT PLAN. THE LIKELIHOOD OF THE ERROR OCCURING AT ALL IS MODERATE, AND USING VIRTUAL WEDGE FOR THE AFFECTED FIELDS SIZES WOULD NOT BE COMMON. IF THE ERROR OCCURS, THE LIKELIHOOD OF SEVERE ADVERSE EFFECTS IS LOW.

    Description of Event or Problem · 0

    NO EVENT INVOLVING ANY PATIENT HAS OCCURRED. A POTENTIAL HEALTH HAZARD WAS DISCOVERED BY A USER WHILE TESTING THE LIMITS OF THE SYSTEM. WHILE TESTING THE SYSTEM LIMITS FOR SIEMENS VIRTUAL WEDGE DOSE CALCULATION, THE USER NOTICED A DISCREPANCY BETWEEN RAYSTATION CALCULATED DOSE AND MEASURED DOSE FOR VERY LARGE FIELD WIDTHS. INVESTIGATION SHOWED THAT THE DIFFERENCE IS DUE TO THE Y JAW OVERTRAVEL LIMIT OF THE LINAC. THE MACHINE MODEL WAS SET UP WITH A 20CM OVERTRAVEL LIMIT. THIS IS THE CORRECT OVERALL MAXIMUM OVERTRAVEL DISTANCE. HOWEVER, WHEN USING VIRTUAL WEDGE, THE OVERTRAVEL LIMIT IS ONLY 10CM. WHEN DEFINING A FIELD WITH SIEMENS VIRTUAL WEDGE THAT WOULD REQUIRE OVERTRAVEL > 10CM, RAYSTATION CALCULATES DOSE AS IF THE JAW COULD OVERTRAVEL TO THE LIMIT DEFINED IN THE MACHINE MODEL, BUT IF THAT LIMIT IS SET TO MORE THAN 10CM, THIS CANNOT BE REALIZED ON THE LINAC. THE RESULT IS A HIGH DOSE PLATEAU REGION IN THE TOE SIDE OF THE VIRTUAL WEDGE FIELD WHICH IS NOT REFLECTED IN THE RAYSTATION CALCULATED DOSE. FIELD SIZES THAT TRIGGER THIS BEHAVIOR ARE OUTSIDE THE RECOMMENDED SPECIFICATION PER SIEMENS' LABELING. HOWEVER, THERE IS NO WARNING IN RAYSTATION THAT THE DOSE CALCULATION WILL BE INCORRECT FOR SUCH FIELDS AND THERE IS NO PARAMETER IN RAYSTATION FOR VIRTUAL WEDGE OVERTRAVEL LIMIT.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00020 (B)(4) RS SIEMENS WEDGE OUTSIDE RECOMENDED SPECIFIKATION. NO EVENT INVOLVING ANY PATIENT HAS OCCURRED. A POTENTIAL HEALTH HAZARD WAS DISCOVERED BY A USER WHILE TESTING THE LIMITS OF THE SYSTEM. WHILE TESTING THE SYSTEM LIMITS FOR SIEMENS VIRTUAL WEDGE DOSE CALCULATION, THE USER NOTICED A DISCREPANCY BETWEEN RAYSTATION CALCULATED DOSE AND MEASURED DOSE FOR VERY LARGE FIELD WIDTHS. INVESTIGATION SHOWED THAT THE DIFFERENCE IS DUE TO THE Y JAW OVERTRAVEL LIMIT OF THE LINAC. THE MACHINE MODEL WAS SET UP WITH A 20CM OVERTRAVEL LIMIT. THIS IS THE CORRECT OVERALL MAXIMUM OVERTRAVEL DISTANCE. HOWEVER, WHEN USING VIRTUAL WEDGE, THE OVERTRAVEL LIMIT IS ONLY 10CM. WHEN DEFINING A FIELD WITH SIEMENS VIRTUAL WEDGE THAT WOULD REQUIRE OVERTRAVEL > 10CM, RAYSTATION CALCULATES DOSE AS IF THE JAW COULD OVERTRAVEL TO THE LIMIT DEFINED IN THE MACHINE MODEL, BUT IF THAT LIMIT IS SET TO MORE THAN 10CM, THIS CANNOT BE REALIZED ON THE LINAC. THE RESULT IS A HIGH DOSE PLATEAU REGION IN THE TOE SIDE OF THE VIRTUAL WEDGE FIELD WHICH IS NOT REFLECTED IN THE RAYSTATION CALCULATED DOSE. FIELD SIZES THAT TRIGGER THIS BEHAVIOR ARE OUTSIDE THE RECOMMENDED SPECIFICATION PER SIEMENS' LABELING. HOWEVER, THERE IS NO WARNING IN RAYSTATION THAT THE DOSE CALCULATION WILL BE INCORRECT FOR SUCH FIELDS AND THERE IS NO PARAMETER IN RAYSTATION FOR VIRTUAL WEDGE OVERTRAVEL LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140739 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4.0-9B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown