BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYCARE

    MDR report key: 17741080 · Received September 13, 2023

    Report

    Report Number
    3007774465-2023-00033
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    June 9, 2023
    Report Date
    April 4, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K200487
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RAYCARE SUPPORTS USER CONFIGURABLE DOCUMENTS THAT CAN CONTAIN DATA FROM RAYCARE IN PREDEFINED RAYCARE DOMAIN OBJECTS (RDO). THE RDOS CAN HAVE DIFFERENT TYPES WHERE THE OBJECT HAS A SINGLE VALUE OR MULTIPLE VALUES (LIST VALUE). DURING THE CONFIGURATION OF A LIST RDO, THE USER CAN SELECT TO DISPLAY ALL VALUES, SELECT A SINGLE VALUE OR SELECT MULTIPLE VALUES. WHEN A DOCUMENT IS CREATED FOR A PATIENT BASED ON A DOCUMENT TEMPLATE WITH ONE OR MORE LIST RDO(S) WHERE SELECTION IS POSSIBLE AND THE DOCUMENT IS NOT IN A DRAFT STATE, THE SELECTED VALUES FOR THE LIST RDOS WILL NOT BE VISIBLE. IN RAYCARE 5B, THE ISSUE OCCURS WHEN THE DOCUMENT IS OPENED OUTSIDE OF THE DOCUMENTS WORKSPACE. IN RAYCARE 6A THE ISSUE OCCURS WHEN THE DOCUMENT IS OPENED FROM A TASK IN THE ACTIVITIES WORKSPACE. WHEN THE DOCUMENT IS OPENED FROM OTHER WORKSPACES, THE SELECTED ITEMS WILL BE DISPLAYED CORRECTLY. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON INCOMPLETE DATA IN THE RAYCARE CONFIGURABLE DOCUMENTS, THIS COULD LEAD TO MISTREATMENT OF THE PATIENT IN DIFFERENT WAYS DEPENDING ON THE DATA LOST.

    Description of Event or Problem · 0

    A USER DETECTED A DIFFERENCE IN DISPLAY OF A RAYCARE CONFIGURABLE DOCUMENT DEPENDING ON WHERE THE DOCUMENT WAS OPENED. THE CONFIGURED "TREATMENT PLAN" DOCUMENT NOTE CONTAINING A LIST OF "RADIATION ONCOLOGY USERS" WAS CORRECTLY READ FROM THE DOCUMENTS WORKSPACE, BUT THE USER THEN NOTICED THAT THIS LIST INFORMATION WAS MISSING IN THE DOCUMENT-OVERVIEW WORKSPACE. THERE WAS NO IMPACT ON THE PATIENT TREATMENT. THE CUSTOMER REPORTED THIS AS A SAFETY COMPLAINT AS A LIST COULD POTENTIALLY CONTAIN CRITICAL INFORMATION.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00033 (B)(6) MISSING DOCUMENT INFO. A USER DETECTED A DIFFERENCE IN DISPLAY OF A RAYCARE CONFIGURABLE DOCUMENT DEPENDING ON WHERE THE DOCUMENT WAS OPENED. THE CONFIGURED "TREATMENT PLAN" DOCUMENT NOTE CONTAINING A LIST OF "RADIATION ONCOLOGY USERS" WAS CORRECTLY READ FROM THE DOCUMENTS WORKSPACE, BUT THE USER THEN NOTICED THAT THIS LIST INFORMATION WAS MISSING IN THE DOCUMENT-OVERVIEW WORKSPACE. THERE WAS NO IMPACT ON THE PATIENT TREATMENT. THE CUSTOMER REPORTED THIS AS A SAFETY COMPLAINT AS A LIST COULD POTENTIALLY CONTAIN CRITICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589876 RAYCARE RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYCARE 5B SP1, 5B SP3, 6A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other