BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAYSTATION

    MDR report key: 5759999 · Received June 29, 2016

    Report

    Report Number
    3007774465-2016-00002
    Event Type
    Other
    Date Received
    June 29, 2016
    Date of Event
    May 20, 2016
    Report Date
    March 19, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K141860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE BELIEVE THE MAIN CAUSE, IN THIS SPECIFIC CASE, IS THE HUMAN FACTOR. THERE ARE THREE PEOPLE INVOLVED IN PLAN APPROVAL (RADIATION THERAPIST, PHYSICIST AND PHYSICIAN). NONE HAVE OBSERVED THE DEVIATION. AT APPROVAL, THE PRIMARY FOCUS IS PROBABLY THE DOSE DISTRIBUTION (AND THE TOTAL DOSE) AND NOT SO MUCH ON THE NUMBER OF FRACTIONS. THE NUMBER OF FRACTIONS IS NOT SO PROMINENT IN RAYSTATION IN THIS SITUATION. YOU NEED TO BE RATHER OBSERVANT RAYSTATION IN THIS SITUATION (= WHEN PERFORMING APPROVAL) TO NOTICE THAT THE NUMBER OF FRACTIONS IS INCORRECT. THE NUMBER OF FRACTIONS BECOMES IMPORTANT ONLY WHEN THE PLAN IS TRANSFERRED TO AND INITIATED IN MOSAIQ (WHICH MEANS YET ANOTHER APPROVAL). THE WAY THINGS ARE WORKING HERE NOW, IT ISN[?]T POSSIBLE IN ANY SIMPLE WAY TO COMPARE THE NUMBER OF FRACTIONS IN THE PLAN TO THE NUMBER IN THE PRESCRIPTION. A POSSIBLE SUGGESTION FOR IMPROVEMENT WOULD BE TO HAVE ACCESS TO A SIMPLE PLAN REPORT (MAX ONE PAGE ON THE SCREEN) WHERE SOME IMPORTANT PLAN PARAMETERS ARE PRESENTED AND THAT COULD EASILY BE CHECKED AGAINST THE PRESCRIPTION.

    Description of Event or Problem · 0

    FOLLOW-UP REPORT RSL: MDR 3007774465-2016-00002 11387 (B)(6) LOW FRACTION DOSE ENTERED. REPORT ON A USE ERROR FOR WHICH THE CLINIC TAKES FULL RESPONSIBILITY. HOWEVER, THE USE ERROR COULD POSSIBLY HAVE BEEN AVOIDED WITH MORE EXPLICIT INFORMATION IN THE USER INTERFACE AND WE, THE MANUFACTURER, ARE INVESTIGATING HOW TO FURTHER IMPROVE THE UI. THE CLINICS INTERNAL INVESTIGATION OF THE INCIDENT HAS NOT BEEN COMPLETED. THIS IS WHAT HAS BEEN REPORTED TO THE MANUFACTURER (TRANSLATED FROM NORWEGIAN): "FOR A HEAD AND NECK PATIENT, 23 FRACTIONS WITH FRACTION DOSE 2GY WAS PRESCRIBED. THIS IS AN UNUSUAL NUMBER OF FRACTIONS FOR THIS DIAGNOSIS NOWADAYS. NORMALLY, THIS WOULD BE A SIMULTANEOUS INTEGRATED BOOST (SIB) WITH 34 FRACTIONS WHERE THE ELECTIVE LYMPH NODES IN THE NECK WOULD RECEIVE 46GY AND THE TUMOR ITSELF GETS 68GY. HOWEVER, THIS PATIENT HAD UNDERGONE SURGERY AND ONLY THE TUMOR BED WAS TO BE TREATED. WHEN PLANNING IN RAYSTATION, THE NUMBER OF FRACTIONS IS ENTERED MANUALLY. BY MISTAKE, 34 FRACTIONS AND 46GY TOTAL DOSE WAS ENTERED (I.E. 1.35GY FRACTION DOSE). WHEN TRANSFERRING THE PLAN FROM RAYSTATION TO MOSAIQ, THE NUMBER OF FRACTIONS MUST ONCE MORE BE ENTERED MANUALLY, BECAUSE MOSAIQ CANNOT IDENTIFY THE NUMBER OF FRACTIONS IN THE IMPORTED RT PLAN (I.E. WITH THE CURRENT SOLUTION, THE NUMBER OF FRACTIONS IN THE PLAN CANNOT BE AUTOMATICALLY TRANSFERRED TO MOSAIQ). THIS TIME, THE CORRECT NUMBER OF FRACTIONS FROM THE PRESCRIPTION WAS USED, I.E. 23. THE PATIENT WAS THEREFORE TREATED WITH A PLAN GIVING 1.35 GY X 23. THE ERROR WAS DISCOVERED BY CHANCE THE DAY AFTER THE PATIENT WAS DONE WITH THE LAST OF THE 23 FRACTIONS. THEREFORE, A COMPENSATION PLAN (2.3 GY X 8) WAS CREATED TO COMPENSATE AS FAR AS POSSIBLE FOR THE TOO LOW DOSE GIVEN INITIALLY."

    Description of Event or Problem · 1

    REPORT ON A USE ERROR FOR WHICH THE CLINIC TAKES FULL RESPONSIBILITY. HOWEVER, THE USE ERROR COULD POSSIBLY HAVE BEEN AVOIDED WITH MORE EXPLICIT INFORMATION IN THE USER INTERFACE AND WE, THE MANUFACTURER, ARE INVESTIGATING HOW TO FURTHER IMPROVE THE UI. THE CLINICS INTERNAL INVESTIGATION OF THE INCIDENT HAS NOT BEEN COMPLETED. THIS IS WHAT HAS BEEN REPORTED TO THE MANUFACTURER (TRANSLATED FROM NORWEGIAN): "FOR A HEAD AND NECK PATIENT, 23 FRACTIONS WITH FRACTION DOSE 2GY WAS PRESCRIBED. THIS IS AN UNUSUAL NUMBER OF FRACTIONS FOR THIS DIAGNOSIS NOWADAYS. NORMALLY, THIS WOULD BE A SIMULTANEOUS INTEGRATED BOOST (SIB) WITH 34 FRACTIONS WHERE THE ELECTIVE LYMPH NODES IN THE NECK WOULD RECEIVE 46GY AND THE TUMOR ITSELF GETS 68GY. HOWEVER, THIS PATIENT HAD UNDERGONE SURGERY AND ONLY THE TUMOR BED WAS TO BE TREATED. WHEN PLANNING IN RAYSTATION, THE NUMBER OF FRACTIONS IS ENTERED MANUALLY. BY MISTAKE, 34 FRACTIONS AND 46GY TOTAL DOSE WAS ENTERED (I.E. 1.35GY FRACTION DOSE). WHEN TRANSFERRING THE PLAN FROM RAYSTATION TO MOSAIQ, THE NUMBER OF FRACTIONS MUST ONCE MORE BE ENTERED MANUALLY, BECAUSE MOSAIQ CANNOT IDENTIFY THE NUMBER OF FRACTIONS IN THE IMPORTED RT PLAN (I.E. WITH THE CURRENT SOLUTION, THE NUMBER OF FRACTIONS IN THE PLAN CANNOT BE AUTOMATICALLY TRANSFERRED TO MOSAIQ). THIS TIME, THE CORRECT NUMBER OF FRACTIONS FROM THE PRESCRIPTION WAS USED, I.E. 23. THE PATIENT WAS THEREFORE TREATED WITH A PLAN GIVING 1.35 GY X 23. THE ERROR WAS DISCOVERED BY CHANCE THE DAY AFTER THE PATIENT WAS DONE WITH THE LAST OF THE 23 FRACTIONS. THEREFORE, A COMPENSATION PLAN (2.3 GY X 8) WAS CREATED TO COMPENSATE AS FAR AS POSSIBLE FOR THE TOO LOW DOSE GIVEN INITIALLY. IT'S HARD TO GIVE A CLEAR ANSWER TO WHY THIS HAPPENED, EXCEPT THE HUMAN FACTOR. THERE ARE THREE PEOPLE INVOLVED IN PLAN APPROVAL (RADIATION THERAPIST, PHYSICIST AND PHYSICIAN). NONE HAVE OBSERVED THE DEVIATION. AT APPROVAL, THE PRIMARY FOCUS IS PROBABLY THE DOSE DISTRIBUTION (AND THE TOTAL DOSE) AND NOT SO MUCH ON THE NUMBER OF FRACTIONS. THE NUMBER OF FRACTIONS IS NOT SO PROMINENT IN RAYSTATION IN THIS SITUATION. YOU NEED TO BE RATHER OBSERVANT TO NOTICE THAT THE NUMBER OF FRACTIONS IS INCORRECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414134 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4.5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other