BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION MEDICAL RADIOTHERAPY SYSTEM

    MDR report key: 22375256 · Received July 1, 2025

    Report

    Report Number
    3011716550-2025-00003
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 3, 2025
    Report Date
    July 1, 2025
    Manufacturer
    REFLEXION MEDICAL, INC
    Product Code
    QVA
    UDI-DI
    00860003983812
    PMA / PMN Number
    DEN220014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THE EVENT DETERMINED THE STANFORD SYSTEM HAD TWO PARAMETER VALUES SET INCORRECTLY (REPORTABLE MALFUNCTION WITHOUT AN ADVERSE EVENT). TWO OF THESE PARAMETERS ARE RELATED TO TREATING MULTIPLE FRACTIONS IN A SINGLE DAY THAT CONTRIBUTED TO THE DEVICE MALFUNCTION IN THIS CASE. THESE TWO PARAMETERS ARE THE FOLLOWING: FRACTION TIME LIMIT HOURS: THIS PARAMETER IS THE NUMBER OF HOURS FOR A GIVEN PATIENT WHO HAS RECEIVED A FRACTION OF RADIOTHERAPY UNTIL THE NEXT FRACTION IS ALLOWED TO BE DELIVERED WITHOUT ANY WARNINGS. WHEN A USER ATTEMPTS TO TREAT A PATIENT WITHIN THE TIME LIMIT, THE SYSTEM WILL DISPLAY A WARNING TO THE USER. THIS ALLOWS THE USER TO AVOID TREATING TWO FRACTIONS TOO CLOSE TOGETHER UNLESS THAT WAS THE PHYSICIAN'S INTENT FOR RADIOTHERAPY. THE SYSTEM DEFAULT FOR THIS VALUE SHOULD BE 12 HOURS. FRACTION LIMIT: THIS PARAMETER IS THE NUMBER OF DISCRETE FRACTIONS THAT ARE ALLOWED TO BE DELIVERED IN THE FRACTION TIME LIMIT HOURS. THIS PROVIDES A HARD LIMIT ON THE NUMBER OF FRACTIONS ABLE TO BE DELIVERED WITHIN THE GIVEN PERIOD DEFINED BY FRACTION TIME LIMIT HOURS. THE SYSTEM DEFAULT FOR THIS VALUE SHOULD BE 2 FRACTIONS. THESE PARAMETER VALUES WERE RESOLVED ON THE STANFORD SYSTEM AS PART OF THE COMPLAINT AND ASSOCIATED SERVICE PROCESS. A CAPA HAS BEEN CREATED TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE ISSUE AND PREVENT RECURRENCE.

    Description of Event or Problem · 0

    THE SYSTEM FAILED TO GENERATE AN EXPECTED WARNING MESSAGE WHEN A PATIENT RECEIVED TREATMENT FOR TWO SEPARATE FRACTIONS ON THE SAME DAY. THIS WARNING IS INTENDED TO NOTIFY USERS OF PRIOR TREATMENT OF THE SAME PATIENT WITHIN A DEFINED TIME WINDOW. IN THIS SPECIFIC CASE, THE CLINICAL USER INTENDED TO TREAT THE PATIENT FOR TWO FRACTIONS, SO NO MISTREATMENT OCCURRED. THE CLINICAL USER TREATED THE PATIENT TWICE IN ORDER TO COMPLETE THE REST OF THE PARTIAL TREATMENT FROM A PRIOR DAY AND THEN HAD THE PATIENT COME BACK AS A BID PATIENT (TWICE SAME DAY ABOUT 8 HOURS APART). THE FIRST SESSION TO TREAT THE COMPLETION OF THE PARTIAL FRACTION OCCURRED AROUND 7:45 AM. THE SECOND SESSION TO TREAT THE NEXT FULL FRACTION OCCURRED AT APPROXIMATELY 3:00 PM. UPON OPENING THE PATIENT RECORD FOR THE SECOND TREATMENT, THE EXPECTED WARNING MESSAGE DID NOT DISPLAY AS IT SHOULD HAVE BASED ON THE SYSTEM DEFAULT CONFIGURATION (TREATING FOR A SECOND TIME WITHIN 12 HOURS). AS NO WARNING MESSAGE APPEARED TO ALERT THE THERAPIST THAT THE PATIENT HAD ALREADY BEEN TREATED FOR THE DAY, A SAFETY CONCERN WAS RAISED DESPITE THE PATIENT BEING TREATED AS INTENDED WITH NO HARM FROM THE MISSING WARNING MESSAGE. INVESTIGATION (SEE H11) DETERMINED THAT NO MISTREATMENT OCCURRED FOR ANY AFFECTED PATIENTS ON THE DATE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418921 REFLEXION MEDICAL RADIOTHERAPY SYSTEM RXM1000 QVA REFLEXION MEDICAL, INC RXM1000 NA 00860003983812

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown