BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTRAC 5.5

    MDR report key: 2449947 · Received February 9, 2012

    Report

    Report Number
    8043933-2012-00002
    Event Type
    Other
    Date Received
    February 9, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 12, 2012
    Manufacturer
    BRAINLAB AG
    Product Code
    IYE
    PMA / PMN Number
    K072506
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE, THE HOSPITAL DID NOT REPORT AN INDICATION OF ANY ADVERSE CLINICAL EFFECT ON THE PTS TO BRAINLAB, (BRAINLAB IS IN CONTINUED COMMUNICATION WITH THE HOSPITAL TO RECEIVE THE HOSPITAL'S ESTIMATION ON POTENTIAL CLINICAL EFFECT ON THE 5 PTS), THERE IS NO INDICATION OF A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE (EXACTRAC), THE BRAINLAB DEVICE (EXACTRAC) WORKS AS INTENDED, THE ACCORDING BRAINLAB MEASURES FOR THE ANTICIPATED POTENTIAL RISK ARE ALREADY IN PLACE, A RISK TO PT HEALTH COULD NOT BE EXCLUDED FOR THESE SPEC CIRCUMSTANCES. THERE IS NO INDICATION OF A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE (EXACTRAC). THE BRAINLAB DEVICE (EXACTRAC) WORKS AS INTENDED. THE ACCORDING BRAINLAB MEASURES FOR THE ANTICIPATED POTENTIAL RISK ARE ALREADY IN PLACE. HUMAN ERROR CONTRIBUTED TO THE EVENTS IN REGARD TO THE BRAINLAB DEVICE INVOLVED (EXACTRAC). CORRECTIVE ACTION - VARIAN EXCHANGED THE FAULTY BOARD OF THE VARIAN MEDICAL SYSTEMS SUPPLIED LINEAR ACCELERATOR COMPONENT. VARIAN INFORMED BRAINLAB THAT THE FAILURE OF THE BOARD IS A RELATIVELY UNCOMMON EVENT. REPLACEMENT RATES FOR THAT BOARD ARE BELOW AVERAGE. BRAINLAB INTENDS TO OFFER ADD'L TRAINING TO THIS HOSPITAL IN REGARD TO THE BRAINLAB DEVICE (EXACTRAC).

    Description of Event or Problem · 1

    THE EXACT COUCH OF THE VARIAN MEDICAL SYSTEMS SUPPLIED LINEAR ACCELERATOR COMPONENT OF THE NOVALIS SYSTEM WAS UNINTENDEDLY LOWERING WHILE ROTATING. A ROTATION OF THE COUCH FOR PT POSITIONING TO APPLY DIFFERENT PLANNED BEAM DIRECTIONS RESULTED IN AN UNINTENDED DOWNWARD VERTICAL MOTION OF THE COUCH, CUMULATIVE FOR EACH COUCH ROTATION. FIVE PTS WERE IRRADIATED WITH SOME PART OF THEIR RADIOTHERAPY TREATMENT OCCURRING WHEN THE COUCH WAS NOT AT THE INTENDED TREATMENT POSITION: 4 PTS AT 2 TREATMENT FRACTIONS EACH, 1 PT AT 3 TREATMENT FRACTIONS. EACH PT WAS A FRACTIONATED CASE WITH 1.8 GRAY PRESCRIBED PER DAY. THE CUMULATIVE DOWNWARD VERTICAL MOTION OF THE COUCH ADDED UP TO AN APPROXIMATE MAXIMUM DEVIATION OF 6MM FOR THE FINAL BEAM DIRECTION OF THE FRACTION. THE PT POSITIONING WAS PERFORMED AND MONITORED USING THE BRAINLAB EXACTRAC PT POSITIONING SYSTEM. THE BRAINLAB EXACTRAC SYSTEM WAS WORKING AS INTENDED. THE HOSPITAL DID NOT REPORT AN INDICATION OF ANY ADVERSE CLINICAL EFFECT ON THE PTS TO BRAINLAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTRAC 5.5 RADIOTHERAPY PATIENT POSITIONING SYSTEM IYE BRAINLAB AG 49905D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other