BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYCARE

    MDR report key: 25218585 · Received May 19, 2026

    Report

    Report Number
    3010034862-2026-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 19, 2026
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN NO ADVERSE EVENT. A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. CONCLUSION: 1) CONCURRENT EDITING: INSTRUCTIONS PROVIDED IN THE BEAM SET DELIVERY NOTE CAN BE LOST WITHOUT THE USER BEING NOTIFIED. THE INCOMPLETE INSTRUCTIONS CAN BE USED DURING TREATMENT DELIVERY. 2) MISSING UPDATE INDICATION: THE INSTRUCTIONS ARE UPDATED AS EXPECTED AND DISPLAYED, BUT THE USER IS NOT NOTIFIED ABOUT THE UPDATE AND MIGHT MISS THE UPDATE. THE DELIVERY OF THE CORRECT TREATMENT TO THE PATIENT IS DEFINED BY MULTIPLE FACTORS NOT ONLY RELATED TO THE TREATMENT DELIVERY PLAN. THE BEAM SET DELIVERY NOTE DOES NOT AFFECT THE APPROVED TREATMENT DELIVERY PLAN SENT TO THE TREATMENT DELIVERY DEVICE. HOWEVER, THE POSITION OF THE PATIENT, THE ACCESSORIES AFFECTING THE DOSE DISTRIBUTION AND THE LOCATION OF THE DELIVERY OF THIS BEAM SET ON THE PATIENT DOCUMENTED IN THE BEAM SET DELIVERY NOTE ALSO DEFINE IF THE TREATMENT DELIVERY WAS CORRECTLY PERFORMED. THE BEAM SET DELIVERY NOTE IS A FREE TEXT FIELD (RAYSEARCH DOES NOT CONTROL THE CONTENT OF THE BEAM SET DELIVERY NOTE) MEANING THAT ANY OF THESE INSTRUCTIONS COULD BE PROVIDED IN THE BEAM SET DELIVERY NOTE. THE EXAMPLES PROVIDED ARE BASED ON CLINICAL EXPERTISE AND KNOWLEDGE AND ARE INTENDED TO DEFINE REALISTIC SCENARIOS.

    Description of Event or Problem · 0

    THE ISSUE WAS FOUND INTERNALLY AT RAYSEARCH. THE PROBLEM INVOLVES THE BEAM SET DELIVERY NOTE THAT IS AVAILABLE IN RAYSTATION, RAYCARE, RAYCARE TREATMENT APPLICATION, RAYTREAT AND RAYCOMMAND AND CAN BE UPDATED FROM ALL THE MENTIONED APPLICATIONS. THE BEAM SET DELIVERY NOTE IS A NOTE THAT IS SPECIFIC FOR THE BEAM SET AND CAN BE USED TO INSTRUCT/INFORM USERS ON ACTIONS NEEDED WHEN DELIVERING THE PATIENT QA AND/OR TREATMENT OF THIS BEAM SET. THE NOTE FUNCTIONALITY IS DESIGNED THAT IT CAN BE UPDATED BY ALL USERS AND ONLY THE LAST VERSION APPLIES. TWO SCENARIOS ARE TO BE CONSIDERED: 1) CONCURRENT EDITING: WHEN MULTIPLE USERS MODIFY THE BEAM SET DELIVERY NOTE SIMULTANEOUSLY IN ANY APPLICATION, THERE IS A RISK OF DATA LOSS. IF THE LAST SAVE IS PERFORMED FROM RAYSTATION OR THE USED TREATMENT APPLICATION (RAYTREAT, THE RAYCARE TREATMENT APPLICATION OR RAYCOMMAND), THE USER WILL BE WARNED: 'UPDATES OCCURRED WHILE YOU WERE MAKING CHANGES TO THE BEAM SET NOTE, YOUR UNSAVED EDITS HAVE BEEN DISCARDED.' THE UNSAVED EDITS WILL BE SHOWN IN THE WARNING. IF THE LAST SAVE IS PERFORMED BY THE USER FROM RAYCARE, PREVIOUSLY ENTERED INFORMATION MAY BE OVERWRITTEN WITHOUT ANY WARNING IN ANY APPLICATION AND THE DATA WILL BE LOST. FORESEEABLE SEQUENCE OF EVENT: USER A OPENS AND EDITS A BEAM SET DELIVERY NOTE IN RAYCARE. USER B OPENS THE SAME DELIVERY NOTE IN RAYCARE/TREATUI/RAYSTATION/RAYCOMMAND. BOTH USERS MAKE CHANGES INDEPENDENTLY. USER B SAVE THE NOTE. USER A SAVES THE NOTE AND SILENTLY OVERWRITES USER B'S NOTE WITHOUT WARNING. 2) MISSING UPDATE INDICATION: IF A NOTE IS UPDATED WHILE A TREATMENT SESSION IS OPEN ON THE TREATMENT APPLICATION, THE USER IS NOT NOTIFIED OF THE CHANGE. ALTHOUGH THE LATEST VERSION IS SAVED AND DISPLAYED, THE USER INTERFACE PROVIDES NO VISUAL INDICATION THAT THE NOTE HAS BEEN UPDATED, MEANING IMPORTANT CHANGE OF INFORMATION MAY GO UNNOTICED. FORESEEABLE SEQUENCE OF EVENT: TREATMENT SESSION IS LOCKED (I.E. THE TREATMENT SESSION IS OPENED FROM TREATMENT APPLICATION OR RAYCOMMAND). RADIATION THERAPIST READS THE BEAM SET DELIVERY NOTE IN THE DELIVERY ROOM (FROM TREATMENT APPLICATION OR RAYCOMMAND). A USER IN RAYCARE OR RAYSTATION UPDATES THE DELIVERY NOTE. NOTE IS UPDATED BUT THE RADIATION THERAPIST IN DELIVERY ROOM IS NOT NOTIFIED AND CONTINUES TREATMENT USING OUTDATED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133644 RAYCARE RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) V2024A SP1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown