BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAYSTATION

    MDR report key: 5759985 · Received June 29, 2016

    Report

    Report Number
    3007774465-2016-00001
    Event Type
    Other
    Date Received
    June 29, 2016
    Date of Event
    May 12, 2016
    Report Date
    March 20, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K141860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERROR WAS DISCOVERED BEFORE COMPLETING THE TREATMENT. THE USER HAS BEEN NEGLIGENT IN NOT PROPERLY EVALUATING THE DOSE. HOWEVER, THE USE ERROR COULD POSSIBLY HAVE BEEN AVOIDED WITH MORE EXPLICIT INFORMATION IN THE UI/REPORT. RS FRACTIONATION HANDLING IS ALREADY EXPLAINED IN THE LABELING AND ALL NECESSARY INFORMATION IS AVAILABLE IN RS4.7, BUT NOT IN AN OPTIMAL WAY. IN RS5, THIS HAS BEEN IMPROVED BY ADDING DOSE/FX TO THE PLAN REPORT.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2016-00001 11387 11297 RS RE-PLANNING FRACTIONATION HANDLING. CLINICAL INCIDENT. UNDER-DOSAGE OF PATIENT DUE TO MISUNDERSTANDING OF FRACTIONATION IN RS4.7 IN A RE-PLANNING SCENARIO. USER ASSUMED FRACTION DOSE WOULD REMAIN THE SAME AFTER RESCALING PRESCRIPTION. THIS WAS A USE ERROR FOR WHICH THE CLINIC TAKE 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. CUSTOMER PLANNED A PATIENT TO 70 GY. THE PHYSICIAN WANTED TO CHANGE IT TO 54 GY THEN A CONE DOWN 16 GY BOOST. CUSTOMER RESCALED THE PRESCRIPTION TO 54 GY BUT DID NOT CHANGE TO THE CORRECT NUMBER OF FRACTIONS. AS SUCH, THE PATIENT WAS TREATED WITH A LOWER DOSE/FX (1.54 GY/FX) THAN WHAT WAS INTENDED (2 GY/FX). THIS WAS CAUGHT 22 FRACTIONS INTO THE INITIAL 27 FRACTIONS.

    Description of Event or Problem · 1

    REPORT ON USE ERROR WITH UNDER-DOSAGE OF A PATIENT DUE TO MISUNDERSTANDING OF FRACTIONATION HANDLING IN A RE-PLANNING SCENARIO. USER ASSUMED FRACTION DOSE WOULD REMAIN THE SAME AFTER RESCALING PRESCRIPTION. THIS WAS A USE ERROR FOR WHICH THE CLINIC TAKE 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. CUSTOMER PLANNED A PATIENT TO 70 GY. THE PHYSICIAN WANTED TO CHANGE IT TO 54 GY THEN A CONE DOWN 16 GY BOOST. CUSTOMER RESCALED THE PRESCRIPTION TO 54 GY BUT DID NOT CHANGE TO THE CORRECT NUMBER OF FRACTIONS. AS SUCH, THE PATIENT WAS TREATED WITH A LOWER DOSE/FX (1.54 GY/FX) THAN WHAT WAS INTENDED (2 GY/FX). THIS WAS CAUGHT 22 FRACTIONS INTO THE INITIAL 27 FRACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414176 RAYSTATION RADIOTHERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4.7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other