BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYCARE

    MDR report key: 16498353 · Received March 7, 2023

    Report

    Report Number
    3010034862-2023-00018
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    July 22, 2020
    Report Date
    February 26, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    UDI-DI
    07350002010341
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON THE INCORRECT IMAGE REGISTRATION DISPLAY, THIS COULD LEAD TO INAPPROPRIATE PATIENT POSITIONING FOR THE NEXT TREATMENT FRACTION. THIS COULD LEAD TO LOCAL OVER-DOSE IN A RISK ORGAN AND/OR UNDER-DOSE TO TARGET.

    Description of Event or Problem · 0

    A SOFTWARE MALFUNCTION WAS DETECTED BY A CUSTOMER PRIOR TO TREATMENT. NO PATIENTS WERE AFFECTED. THE FIRST TREATMENT FRACTION HAD BEEN PERFORMED AND WAS TO BE REVIEWED IN OIR. THERE WAS AN ERROR MESSAGE SAYING THAT THE REVIEW FILES WERE NOT AVAILABLE. USER CALLED SUPPORT. IT WAS VERIFIED IN RAYCARE PACS THAT DATA WAS INDEED AVAILABLE. THE TREATMENT IMAGE WAS THEN OPENED IN RAYCARE IMAGE VIEWER AND IT WAS NOTICED THAT THE IMAGE REGISTRATION WAS NOT DONE WITH THE PLANNING IMAGE SET. THE REGISTRATION OBJECT USED WAS CORRECT, BUT THE REGISTRATION WAS DONE ON THE WRONG IMAGE SET. THE BUG IS THAT THE SW SELECTS THE FIRST IMAGE SET WITH THE SAME FRAME OF REFERENCE, RATHER THAN SELECTING THE PLANNING IMAGE SET.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSA: MRD 3010034862-2023-00018 65340 RC OFFLINE IMAGE REVIEW. A SOFTWARE MALFUNCTION WAS DETECTED BY A CUSTOMER PRIOR TO TREATMENT. NO PATIENTS WERE AFFECTED. THE FIRST TREATMENT FRACTION HAD BEEN PERFORMED AND WAS TO BE REVIEWED IN OIR. THERE WAS AN ERROR MESSAGE SAYING THAT THE REVIEW FILES WERE NOT AVAILABLE. USER CALLED SUPPORT. IT WAS VERIFIED IN RAYCARE PACS THAT DATA WAS INDEED AVAILABLE. THE TREATMENT IMAGE WAS THEN OPENED IN RAYCARE IMAGE VIEWER AND IT WAS NOTICED THAT THE IMAGE REGISTRATION WAS NOT DONE WITH THE PLANNING IMAGE SET. THE REGISTRATION OBJECT USED WAS CORRECT, BUT THE REGISTRATION WAS DONE ON THE WRONG IMAGE SET. THE BUG IS THAT THE SW SELECTS THE FIRST IMAGE SET WITH THE SAME FRAME OF REFERENCE, RATHER THAN SELECTING THE PLANNING IMAGE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63768 RAYCARE RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYCARE 2C SP2, 2C SP3, 3A, 3A SP1, 3B, 4A 07350002010341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown