BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYCARE

    MDR report key: 18310262 · Received December 12, 2023

    Report

    Report Number
    3010034862-2023-00034
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    November 12, 2023
    Report Date
    March 20, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO MALFUNCTION. THE INCIDENT WAS CAUSED BY HUMAN ERROR BY RAYSEARCH SERVICE PERSONNEL. ALL THE DATA THAT IS EXPECTED TO BE NEEDED FOR TREATMENT DECISIONS IS IN RAYCARE OIS, WHICH WAS SUCCESSFULLY RESTORED AFTER THE HARDWARE FAILURE. HOWEVER, AN ISSUE OF DATA COMPLETENESS AND TRACEABILITY DUE TO MISSING PACS DATA REMAINS FOR THE CLINIC. IF A MORE EXTENSIVE LOSS OF PATIENT DATA SHOULD OCCUR THIS COULD LEAD TO SIGNIFICANT DELAYS IN TREATMENT AND POTENTIALLY AFFECT FUTURE TREATMENT AS RECORDS OF ALREADY PERFORMED TREATMENT COULD BE INCOMPLETE. NORMALLY, ENSURING PROPER BACKUPS IS THE RESPONSIBILITY OF EACH CLINIC. HOWEVER, FOR THIS PARTICULAR CLINIC, BACKUPS WERE MANAGED BY RAYSEARCH.

    Description of Event or Problem · 0

    DURING A MAINTENANCE WINDOW FOR INCREASING THE AMOUNT OF STORAGE AND SOME OTHER IMPROVEMENTS, CLINICAL RAYCARE DATA WAS LOST. THIS RESULTED IN DELAY TO TREATMENT BY ONE DAY. IN AN INCIDENT WHERE THE HARDWARE USED FOR THE CLINICAL SYSTEM FAILED DURING A MAINTENANCE EVENT, ALL RAYCARE DATA WAS LOST. RAYCARE NEEDED TO BE REINSTALLED AND ALL DATABASES RESTORED. FOR AS YET UNKNOWN REASONS, BACKUPS OF THE PACS DATA WERE NOT AVAILABLE, SO PACS DATA SUCH AS PATIENT IMAGES AND TREATMENT SUMMARY RECORDS HAS BEEN IRRETRIEVABLY LOST. NO PATIENT WAS HARMED. TREATMENT WAS DELAYED ONE DAY FOR 14 PATIENTS. ALL THE DATA THAT ARE EXPECTED TO BE NEEDED FOR TREATMENT DECISIONS IS IN RAYCARE OIS, SO ONGOING TREATMENT COULD BE CONTINUED.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSA: MDR 3010034862-2023-00034 (B)(6) RAYCARE DATA LOST. THERE WAS NO SOFTWARE MALFUNCTION; THE ISSUE WAS CAUSED BY TWO SEPARATE ERRORS: 1. HARDWARE MALFUNCTION. 2. ERRONEOUS CONFIGURATION OF BACKUPS. DURING A MAINTENANCE WINDOW FOR INCREASING THE AMOUNT OF STORAGE AND SOME OTHER IMPROVEMENTS, CLINICAL RAYCARE DATA WAS LOST. THIS RESULTED IN DELAY TO TREATMENT BY ONE DAY. IN AN INCIDENT WHERE THE HARDWARE USED FOR THE CLINICAL SYSTEM FAILED DURING A MAINTENANCE EVENT, ALL RAYCARE DATA WAS LOST. RAYCARE NEEDED TO BE REINSTALLED AND ALL DATABASES RESTORED. FOR AS YET UNKNOWN REASONS, BACKUPS OF THE PACS DATA WERE NOT AVAILABLE, SO PACS DATA SUCH AS PATIENT IMAGES AND TREATMENT SUMMARY RECORDS HAS BEEN IRRETRIEVABLY LOST. NO PATIENT WAS HARMED. TREATMENT WAS DELAYED ONE DAY FOR 14 PATIENTS. ALL THE DATA THAT ARE EXPECTED TO BE NEEDED FOR TREATMENT DECISIONS IS IN RAYCARE OIS, SO ONGOING TREATMENT COULD BE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693710 RAYCARE RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYCARE 5B SP3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other