BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION MEDICAL RADIOTHERAPY SYSTEM

    MDR report key: 22092325 · Received May 27, 2025

    Report

    Report Number
    3011716550-2025-00002
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 27, 2025
    Manufacturer
    REFLEXION MEDICAL, INC.
    Product Code
    QVA
    UDI-DI
    00860003983812
    PMA / PMN Number
    DEN220014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE EVENT DETERMINED THE EVENT WAS CAUSED BY USE ERROR, WITH THE SYSTEM BEHAVING AS DESIGNED. INVESTIGATION DETERMINED THE USER INADVERTENTLY MISCONFIGURED THE CUSTOMER-ENTERED HOUNSFIELD UNIT (HU) DENSITY TABLE DURING SETUP BY OMITTING THE ENTRY FOR AIR AT -1000 HU. THE CONSEQUENCE OF NOT HAVING AN ENTRY FOR AIR WAS THAT THE TREATMENT PLANNING SYSTEM (TPS) WOULD INCORRECTLY CONSIDER AIR (OUTSIDE THE BODY) AS ATTENUATING MATERIAL THAT CAN ABSORB DOSE (NOTE: AIR DOES NOT PHYSICALLY ABSORB DOSE) RESULTING IN DELIVERY OF MORE DOSE TO THE TARGET TO ACHIEVE THE PRESCRIPTION DOSE. REVIEW OF THE LOGS AND SYSTEM METRICS FOR THE PATIENT ACROSS THEIR RESPECTIVE TREATMENT FOUND NO SYSTEM MALFUNCTION OR INTERRUPTIONS. ALL COUCH, GANTRY AND COLLIMATION PARAMETERS WERE WITHIN TOLERANCE DURING THE TREATMENT. THE DELIVERED MUS WERE AS PRESCRIBED BY THE PLAN. LABELING INSTRUCTIONS ARE PROVIDED TO USERS REGARDING CREATING AND EDITING HU DENSITY TABLE IN THE REFLEXION X1 PHYSICS GUIDE. AFTER THE EVENT CUSTOMER RETRAINING WAS PROVIDED ON THE REFLEXION X1 PHYSICS GUIDE. THE CLINICAL SITE INFORMED THE PATIENT AND INCREASED THE FOLLOW-UP FREQUENCY FOR PATIENT MONITORING. THE RISK OF SERIOUS ADVERSE EFFECTS IS LOW. H3 DEVICE WAS EVALUATED, LOGS WERE REVIEWED AND FOUND NO SYSTEM MALFUNCTIONS OR INTERRUPTIONS.

    Description of Event or Problem · 0

    A 79-YEAR-OLD MALE PATIENT WITH METASTATIC PROSTATE CANCER WAS SCHEDULED TO RECEIVE 30 GY IN 3 FRACTIONS OF IMAGE-GUIDED RADIOTHERAPY (IGRT) TO A METASTATIC LESION IN THE RIGHT ISCHIUM USING THE REFLEXION X1 SYSTEM. ALL THREE FRACTIONS WERE DELIVERED ON THE RXM SYSTEM. THE RADIATION ONCOLOGIST REVIEWED THE DELIVERED DOSIMETRY AND FOUND THAT THE PLANNING TARGET VOLUME (PTV) RECEIVED A 74% HIGHER DOSE THAN INITIALLY INTENDED. HOWEVER, ALL ORGAN-AT-RISK (OAR) DOSE CONSTRAINTS WERE WITHIN CLINICALLY ACCEPTABLE LIMITS, AND NO MAJOR CLINICAL CONCERNS WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728605 REFLEXION MEDICAL RADIOTHERAPY SYSTEM RXM1000 QVA REFLEXION MEDICAL, INC. RXM1000 NA 00860003983812

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male