BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEVION S250I

    MDR report key: 18625672 · Received February 1, 2024

    Report

    Report Number
    3007087027-2024-00001
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 12, 2024
    Report Date
    January 30, 2024
    Manufacturer
    MEVION MEDICAL SYSTEMS, INC.
    Product Code
    LHN
    UDI-DI
    00864366000124
    PMA / PMN Number
    K172848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MISDELIVERY WAS A RESULT OF USER ERROR, AS THE ALIGNMENT POSITION CORRECTIONS WERE INADVERTENTLY NOT APPLIED BY THE USER, DESPITE THIS BEING A STANDARD PART OF THE WORKFLOW AS DESCRIBED IN THE USER MANUAL. HOWEVER, THERE WAS NO SIGNIFICANT DOSE INCREASE TO ORGANS AT RISK AND NO SIGNIFICANT UNDERDOSE TO THE TUMOR AND THEREFORE NO ADJUSTMENTS TO THE TREATMENT WERE REQUIRED TO COMPENSATE FOR THIS ERROR. ALTHOUGH, THERE WAS NO EVIDENCE OF IMMEDIATE SERIOUS INJURY, AN ACCIDENTAL RADIATION OCCURENCE DID OCCUR, ATTRIBUTED TO USER ERROR AT THIS FACILITY IN THE NETHERLANDS. THERE ARE NO OTHER KNOWN INSTANCES OF THIS OCCURING SINCE THE DEVICE WAS CLEARED IN 2017. AS THE RADIATION DOSE COULD POTENTIALLY LEAD TO SERIOUS INJURY, MEVION IS REPORTING THE INCIDENT TO FDA.

    Description of Event or Problem · 0

    ON FRIDAY JANUARY 12, THE FIRST BEAM OF A 5-BEAM FRACTION WAS DELIVERED TO AN INCORRECT POSITION WITH ERRORS OF 3.4 CM IN VERTICAL, 9.3 CM IN LONGITUDINAL AND 6.9 CM IN LATERAL, RESULTING IN AN OVERDOSE TO SURROUNDING TISSUE AND AN UNDERDOSE TO THE TARGET. THIS ERROR WAS CALCULATED TO AMOUNT TO A +/- 2.5% DOSE ERROR (~1.5 GY) OVER THE COURSE OF A SINGLE TREATMENT. THERE WAS NO ADVERSE REACTION TO THE PATIENT REPORTED BY THE FACILITY. THE ROOT CAUSE OF THE INCORRECT DELIVERY WAS DETERMINED TO BE USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278701 MEVION S250I LHN MEVION MEDICAL SYSTEMS, INC. MEVION S250I N/A 00864366000124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other