BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPLAN RT DOSE

    MDR report key: 1914504 · Received November 30, 2010

    Report

    Report Number
    8043933-2010-00017
    Event Type
    Other
    Date Received
    November 30, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K080888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL THERE ARE NO CLINICAL CONSEQUENCES TO BE EXPECTED FOR THE PT. PLANNED WERE 4 ARC BEAMS FOR A TOTAL OF 1 FRACTION OF 24 GY, FOR BRAIN METASTASIS. THE THERAPIST BEGAN TREATING THE FIRST ARC BEAM AND NOTICED THAT THE CONICAL COLLIMATOR WAS NOT IN PLACE AND STOPPED TREATMENT. PARTIAL TREATMENT WAS DELIVERED (804 MU OUT OF 1320 MU) FOR THE FIRST ARC BEAM WITH A 5X5 FIELD SIZE SETTING W/O THE PLANNED 7.5 MM CONICAL COLLIMATOR IN PLACE. ERROR OF USE RESULTING IN UNINTENDED PT TREATMENT. NO FAILURE OF THE DEVICE WAS STATED BY THE HOSPITAL. ROOT CASE: HUMAN ERROR. CORRECTIVE AND PREVENTIVE ACTIONS: SINCE: THERE IS NO INDICATION OF A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE, THE BRAIN LAB DEVICE WORKS ACCORDING TO SPECIFICATION, THIS ISSUE HAS BEEN RECOGNIZED/IDENTIFIED AS "HUMAN ERROR" BY BRAINLAB, THERE ARE NO CORRECTIVE ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    RADIOTHERAPY TREATMENT OF ONE PT WAS STARTED W/O THE PLANNED, INTENDED CONICAL COLLIMATOR MOUNTED TO THE LINEAR ACCELERATOR. IPLAN RT DOSE WAS USED TO CREATE THE RADIOTHERAPY TREATMENT PLAN. ACCORDING TO THE HOSPITAL THERE ARE NO CLINICAL CONSEQUENCES TO BE EXPECTED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPLAN RT DOSE RADIOTHERAPY TREATMENT PLANNING SW MUJ BRAINLAB AG IPLAN RT DOSE 4.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other