BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 6066085 · Received October 31, 2016

    Report

    Report Number
    3007774465-2016-00004
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    August 31, 2016
    Report Date
    March 20, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K160093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT THEY HAD SOME ISSUES WITH THEIR QA SOFTWARE, "DOUBLE CHECK SOFTWARE" AND LINAC AND SOME DELAY WITH PREPARATION OF PLAN FOR DIFFERENT PATIENTS. EVENT IS ATTRIBUTED TO USE ERROR.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2016-00004 (B)(6) LOW NUMBER OF FRACTIONS ENTERED. USE ERROR. A PATIENT WAS OVER IRRADIATED DURING SEVERAL FRACTION. THE FRACTION DOSE TO TARGET AND ALL RISK ORGANS WAS HIGHER THAN INTENDED. THE PATIENT RECEIVED 20 FX WITH 2,8GY BEFORE THE ERROR WAS DISCOVERED. THE CLINIC HAS ORGANIZED A PATIENT FOLLOW-UP TO DETECT ANY POST-IRRADIATION CONSEQUENCES. INTENDED PRESCRIPTION FOR A PROSTATE CASE WAS 2GY*35FX=70GY. USER ENTERED THE WRONG #FX, 25 INSTEAD OF 35, IN RAYSTATION AND PLANNED FOR 70 GY IN 25FX, CORRESPONDING TO A FRACTION DOSE OF 2,8GY. THE PLAN WAS EXPORTED TO MOSAIQ. THE PRESCRIPTION 2GY*35FX=70GY WAS ALREADY SET IN MOSAIQ AND WAS NOT TRANSFERRED FROM RAYSTATION. AS THE MU/FX IN THE PLAN WAS BASED ON 25FX, THIS RESULTED IN A TOTAL PLAN DOSE OF 2,8GY*35FX=98GY. IN MOSAIQ, A CHECK OF FRACTION DOSE/BEAM WAS PERFORMED. THE DOSE VALUE AT ISOCENTER IS USED AS A REFERENCE AND COMPARED WITH THE PRESCRIPTION. HOWEVER, THE DOSE IN ISOCENTER USUALLY DOES NOT EXACTLY MATCH THE PRESCRIPTION AND THE VALUE CAN THEN BE MANUALLY EDITED IN MOSAIQ. THEREFORE, THE USERS ARE USED TO THERE BEING A MISMATCH. THEY NORMALLY DOUBLE CHECKS MU AND DOSE, BUT IN THIS CASE THE PROBLEM WITH THE TOO HIGH FRACTION DOSE WAS NOT DISCOVERED BEFORE TREATMENT.

    Description of Event or Problem · 1

    A PROSTATE PATIENT WAS PLANNED FOR RADIATION THERAPY. INTENDED PRESCRIPTION FOR THE PROSTATE CASE WAS 2GY * 35FX = 70GY. USER ENTERED THE WRONG #FX, 25 INSTEAD OF 35, IN RAYSTATION AND PLANNED FOR 70 GY IN 25FX, CORRESPONDING TO A FRACTION DOSE OF 2,8GY. THE PLAN WAS EXPORTED TO MOSAIQ. THE PRESCRIPTION 2GY * 35FX = 70GY WAS ALREADY SET IN MOSAIQ AND WAS NOT TRANSFERRED FROM RAYSTATION. AS THE MU/FX IN THE PLAN WAS BASED ON 25FX, THIS RESULTED IN A TOTAL PLAN DOSE OF 2,8GY * 35FX = 98GY. IN MOSAIQ, A CHECK OF FRACTION DOSE/BEAM WAS PERFORMED. THE DOSE VALUE AT ISOCENTER IS USED AS A REFERENCE AND COMPARED WITH THE PRESCRIPTION. HOWEVER, THE DOSE IN ISOCENTER USUALLY DOES NOT EXACTLY MATCH THE PRESCRIPTION AND THE VALUE CAN THEN BE MANUALLY EDITED IN MOSAIQ. THEREFORE, THE USERS ARE USED TO THERE BEING A MISMATCH. THEY NORMALLY DOUBLE CHECKS MU AND DOSE, BUT IN THIS CASE THE PROBLEM WITH THE TOO HIGH FRACTION DOSE WAS NOT DISCOVERED BEFORE TREATMENT. CUSTOMER REPORTS THAT THEY HAD SOME ISSUES WITH THEIR QA SOFTWARE, "DOUBLE CHECK SOFTWARE" AND LINAC AND SOME DELAY WITH PREPARATION OF PLAN FOR DIFFERENT PATIENTS. IN ALL, THEY HAD A STRESSFUL WEEK THAT COULD EXPLAIN THEIR MISTAKE AND WHY THEY DID NOT DISCOVER THE ERROR BEFORE TREATMENT. THE FRACTION DOSE TO TARGET AND ALL RISK ORGANS WAS HIGHER THAN INTENDED. THE PATIENT RECEIVED 20 FX WITH 2,8GY BEFORE THE ERROR WAS DISCOVERED. FOR THE MOMENT, NO CONSEQUENCE TO THE PATIENT IS KNOWN. THE CLINIC HAS ORGANIZED A PATIENT FOLLOW-UP TO DETECT ANY POST-IRRADIATION CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719646 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other