BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 2600588 · Received June 1, 2012

    Report

    Report Number
    2950347-2012-00001
    Event Type
    Injury
    Date Received
    June 1, 2012
    Date of Event
    April 27, 2012
    Report Date
    June 1, 2012
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K120067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOSE TRACKING FEATURE IN MOSAIQ ENABLES USERS TO MONITOR AND TRACK CUMULATIVE DOSE DELIVERED TO SITES WHEN TREATING PRESCRIPTION SITES AND TREATMENT FIELDS. THE DOSIMETRY SETUP WINDOW AUTOMATICALLY DISPLAYS PRIMARY DOSE TRACKING SITES AND CUMULATIVE PRIMARY DOSE TRACKING SITES. SECONDARY DOSE TRACKING SITES AND SECONDARY CUMULATIVE DOSE TRACKING SITES TO THE DOSIMETRY SETUP WINDOW CAN ALSO BE ADDED. THIS ENABLES SITES TO MONITOR AND TRACK DOSE TO ALL SITES RELATED TO THE PRESCRIBED SITE. IN THIS CASE, DOSE TRACKING WAS ENABLED IN DEPT SET UP, SITE CREATED A PRESCRIPTION SITE AND TREATMENT FIELD BUT DID NOT SELECT DOSIMETRY TRACKING. SITE CONTINUED TO TREAT THE PT WITHOUT DOSIMETRY TRACKING IN PLACE. SITE WAS WARNED EACH AND EVERY TIME OVER THE COURSE OF TREATMENT THAT THE DOSIMETRY TRACKING HAD NOT BEEN ASSIGNED, BUT THEY CONTINUALLY ACKNOWLEDGED THE WARNING MESSAGE AND CONTINUED TREATMENT. AS A RESULT, THE PT WAS TREATED WITH 4 EXTRA FRACTIONS. THE FX DOSE MISMATCH WAS DISPLAYED UPON THE CREATION OF SITE "SCALP AT 90 PERCENT". FIELD 2 WAS CREATED AND TREATED. (B)(6) DAYS LATER, FIELD 2 WAS HIDDEN AND FIELD 2A BEGAN TREATMENT. DURING THE ENTIRE TREATMENT. DURING THE ENTIRE TREATMENT OF FIELD 2A, THE SITE WAS WARNED THAT THE DOSE SITE COEFF WAS NOT DEFINED. ON (B)(6), THE USER WAS WARNED AND ACKNOWLEDGED THE WARNING MESSAGE "DOSE SITE COEFFICIENT HAS EITHER NOT BEEN DEFINED OR SET UP SO TREATMENT OF THIS FIELD WILL NOT CONTRIBUTE DOSE TO THE RX SITE". ON (B)(6), IT APPEARS THE DOSIMETRY WAS UPDATED AS THE INBOUND TREATMENT CHECK INDICATES THAT FRACTION AND TOTAL DOSE WILL BE EXCEEDED. SITE ADMITS THEY WERE GETTING THE MESSAGE THAT DOSIMETRY HAD NOT BEEN RUN BUT WOULD JUST OK THROUGH THEM. MISTREATMENT PRESUMPTIVELY RESULTED IN SERIOUS INJURY. FIELD 2A WAS ERRANTLY DELIVERED FOR 14 FRACTIONS INSTEAD OF THE PLANNED 10 FRACTIONS. EACH OF THE EXTRA FRACTIONS REPRESENTED A PER FRACTION OVERDOSE OF 200 CGY / 2 GY, WHICH FALLS UNDER THE FRACTIONAL OVERDOSE THRESHOLD OF 400 CGY / 4 GY ESTABLISHED FOR DE FACTO SERIOUS INJURY. TOTAL OVERDOSE WAS 800 CGY / 8 GY, WHICH IS 25% OF PTV. ALTHOUGH THE SITE HAS NOT ALLEGED ANY ACTUAL INJURY AS A RESULT OF THE MISTREATMENT, THIS EXCEEDS THE ESTABLISHED PTV THRESHOLD FOR DE FACTO SERIOUS INJURY. CAUSE WAS USER ERROR. MOSAIQ OPERATED AS INTENDED AND ACCORDING TO ITS DESIGN SPECIFICATIONS, WITHOUT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIQ IYE IMPAC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other