BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTRAC

    MDR report key: 2997999 · Received August 22, 2007

    Report

    Report Number
    8043933-2007-00011
    Event Type
    Other
    Date Received
    August 22, 2007
    Date of Event
    July 27, 2007
    Report Date
    August 22, 2007
    Manufacturer
    BRAINLAB AG
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACTRAC SYSTEM IS IN USE SINCE (B)(6) 2000. PT INJURY CAN NOT BE EXCLUDED AT THIS POINT OF TIME. THE FINAL CLINICAL EFFECT ON THE PT IS FOLLOWED UP BY THE MEDICAL CENTER REGARDING POTENTIAL LONG-TERM EFFECTS. THE ADVERSE INCIDENT HAS BEEN RECOGNIZED/IDENTIFIED BY BRAINLAB AS AN ISOLATED "HUMAN ERROR" AT THIS MEDICAL CENTER.

    Description of Event or Problem · 1

    ON (B)(6) 2007, BRAINLAB HAS BEEN INFORMED BY THE MEDICAL CENTER THAT A PT HAS BEEN IRRADIATED FOR SEVERAL FRACTIONS WITH THE PT SET UP TO AN UNINTENDED POSITION AT THE LINEAR ACCELERATOR (LINAC). THE PT WAS POSITIONED AT THE LINAC USING THE BRAINLAB EXACTRAC DEVICE. THE USER MODIFIED THE ORIGINALLY INTENDED PT POSITION INSIDE THE TREATMENT PLAN AFTER THE PT POSITION WAS ALREADY IMPORTED INTO THE EXACTRAC DEVICE. FOR THE TREATMENT THE ORIGINAL PT POSITION WAS USED INSTEAD OF THE INTENDED CHANGED POSITION. NO MALFUNCTION OF THE DEVICE HAS BEEN EITHER REPORTED OR IDENTIFIED; THE DEVICE IS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTRAC RADIOTHERAPY PATIENT POSITIONING SYSTEM IYE BRAINLAB AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other