BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGIN DATA MANAGEMENT (SOFTWARE COMPONENT)

    MDR report key: 21179265 · Received January 17, 2025

    Report

    Report Number
    8043933-2025-00005
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 17, 2024
    Report Date
    February 11, 2025
    Manufacturer
    BRAINLAB AG
    Product Code
    QIH
    PMA / PMN Number
    K243698
    Removal / Correction Number
    96241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, BECAUSE IN THE EVENT THAT AN AUTOMATIC INCORRECT MERGE OF UNRELATED PATIENT RECORDS IS NOT DETECTED BY THE USER, IT COULD, IN A WORST CASE SCENARIO, MISLEAD THE USER, LEADING TO INEFFECTIVE TREATMENT OR SERIOUS INJURY, ALTHOUGH ACCORDING TO THE HOSPITAL: IT ONLY USES THE DEVICE TO PERFORM PRE-PLANNING FOR TREATMENTS. ONCE FUSIONS/CONTOURING ARE/IS COMPLETED, THE DATA IS EXPORTED TO A THIRD PARTY FOR TREATMENT PLANNING. IN ALL THE KNOWN CASES, NO DATA THAT WAS AFFECTED BY THIS ISSUE WAS EXPORTED TO A THIRD PARTY FOR TREATMENT PLANNING. THUS, THERE WAS NO NEGATIVE CLINICAL EFFECT ON PATIENT TREATMENT DUE TO THIS ISSUE. H6: THROUGH THE INVESTIGATION OF THIS ISSUE, BRAINLAB HAS DETERMINED TWO SOFTWARE ANOMALIES IN BRAINLAB ORIGIN DATA MANAGEMENT (ODM) SOFTWARE VERSIONS 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1, THAT LEAD TO AUTOMATIC AND INCORRECT MERGES OF PATIENT RECORDS, WITHOUT ANY USER NOTIFICATION, UNDER SPECIFIC CIRCUMSTANCES. CIRCUMSTANCES IN WHICH THE ISSUE OCCURS: THE PROBLEM OCCURS IF SPECIFIC WORKFLOWS ARE APPLIED EITHER IN THE BRAINLAB PATIENT SELECTION APPLICATION, OR IN A HOSPITAL INFORMATION SYSTEM (HIS) THAT IS CONNECTED TO THE ABOVE-LISTED VERSIONS OF BRAINLAB ODM SOFTWARE: 1. IF THE PATIENT ID IS CHANGED VIA MERGE OR EDIT FUNCTION AND SUBSEQUENTLY ONLY THE GENDER OF THAT PATIENT RECORD IS CHANGED, OR, 2. IF THE PATIENT ID OF ONE PATIENT RECORD IS CHANGED FROM ITS ORIGINAL VALUE TO A NEW VALUE AND SUBSEQUENTLY, THIS ORIGINAL VALUE IS APPLIED (VIA MERGE OR EDIT FUNCTION) AS THE TARGET PATIENT ID OF ANOTHER PATIENT RECORD. H7 BRAINLAB IS IN THE PROCESS OF ISSUING FIELD SAFETY CORRECTIVE ACTION (FSCA) INFORMATION FOR THIS POTENTIAL SAFETY ISSUE TO THE FDA AS WELL AS ALL APPLICABLE REGULATORY AUTHORITIES. BRAINLAB SUBMITTED A 21 CFR 806 REPORT TO THE FDA ON FEBRUARY 4TH, 2025 (RES NUMBER (B)(4)). BRAINLAB WILL INFORM ALL AFFECTED CUSTOMERS OF THE POTENTIAL SAFETY ISSUE WHEN USING THE RELEVANT BRAINLAB ORIGIN DATA MANAGEMENT (ODM) SOFTWARE VERSIONS, THE INTERMEDIATE ACTIONS USERS SHALL APPLY TO AVOID THE ISSUE, AND THE CORRECTIVE ACTIONS THAT BRAINLAB IS TAKING TO CORRECT THIS ISSUE. BRAINLAB INITIATED THE DISTRIBUTION OF THE NOTIFICATION LETTERS ON FEBRUARY 7TH, 2025.

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, BECAUSE IN THE EVENT THAT AN AUTOMATIC INCORRECT MERGE OF PATIENT DATA IS NOT DETECTED BY THE USER, IT COULD, IN A WORST-CASE SCENARIO, RESULT IN TREATMENT ERROR OR SERIOUS INJURY, ALTHOUGH ACCORDING TO THE HOSPITAL: IT ONLY USES THE DEVICE TO PERFORM PRE-PLANNING FOR TREATMENTS. ONCE FUSIONS/CONTOURING ARE/IS COMPLETED, DATA IS EXPORTED TO A THIRD PARTY FOR TREATMENT PLANNING. IN ALL THE KNOWN CASES, NO DATA THAT WAS AFFECTED BY THIS ISSUE WAS EXPORTED TO A THIRD PARTY FOR TREATMENT PLANNING. THUS, THERE WAS NO NEGATIVE CLINICAL EFFECT ON PATIENT TREATMENT DUE TO THIS ISSUE. H6, H7: BRAINLAB CONTINUES TO INVESTIGATE THE ISSUE AND WILL CONCLUDE ON CORRESPONDING ACTIONS AS SOON AS POSSIBLE. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT TO THE FDA UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    A CUSTOMER USING BRAINLAB ORIGIN DATA MANAGEMENT 3.2 INFORMED BRAINLAB ABOUT AN ISSUE WHERE A PATIENT RECORD WAS FOUND TO BE COMBINED WITH ANOTHER UNRELATED PATIENT RECORD. ACCORDING TO THE HOSPITAL: - IT ONLY USES THE DEVICE TO PERFORM PRE-PLANNING FOR TREATMENTS. ONCE FUSIONS/CONTOURING ARE/IS COMPLETED, THE DATA IS EXPORTED TO A THIRD PARTY FOR TREATMENT PLANNING. - IN ALL THE KNOWN CASES, NO DATA THAT WAS AFFECTED BY THIS ISSUE WAS EXPORTED TO A THIRD PARTY FOR TREATMENT PLANNING. THUS, THERE WAS NO NEGATIVE CLINICAL EFFECT ON PATIENT TREATMENT DUE TO THIS ISSUE.

    Description of Event or Problem · 0

    A CUSTOMER THAT USES BRAINLAB RT ELEMENTS 4.0 INFORMED BRAINLAB ABOUT AN ISSUE WHERE A PATIENT RECORD WAS FOUND TO BE COMBINED WITH ANOTHER UNRELATED PATIENT RECORD. ACCORDING TO THE HOSPITAL: IT ONLY USES THE DEVICE TO PERFORM PRE-PLANNING FOR TREATMENTS. ONCE FUSIONS/CONTOURING ARE/IS COMPLETED, THE DATA IS EXPORTED TO A THIRD PARTY FOR TREATMENT PLANNING. IN ALL THE KNOWN CASES, NO DATA THAT WAS AFFECTED BY THIS ISSUE WAS EXPORTED TO A THIRD PARTY FOR TREATMENT PLANNING. THUS, THERE WAS NO NEGATIVE CLINICAL EFFECT ON PATIENT TREATMENT DUE TO THIS ISSUE. BRAINLAB CONTINUES TO INVESTIGATE THE ISSUE AND WILL CONCLUDE ON CORRESPONDING ACTIONS AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141387 ORIGIN DATA MANAGEMENT (SOFTWARE COMPONENT) AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE QIH BRAINLAB AG 30074-04C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other