BEUDAMED
    FDA Adverse Event Other Summary report: N

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    MDR report key: 1172703 · Received September 13, 2008

    Report

    Report Number
    3004022368-2008-00002
    Event Type
    Other
    Date Received
    September 13, 2008
    Date of Event
    May 4, 2008
    Report Date
    September 11, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    MUJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TREATMENT PLANNER IGNORED THE WARNING MESSAGE 'OPTIMIZATION IS NOT ALLOWED' FOR MOTORIZED WEDGE BEAM TYPE WHEN SWITCHING FROM STANDARD PLANNING TO IMRT PLANNING. THE IMRT PLAN CREATED IN PINNACLE3 CALLED FOR A MOTORIZED WEDGE ON 2 OF 3 BEAMS. WHEN THE PLAN WAS EXPORTED TO THE SITE'S IN-HOUSE DEVELOPED SOFTWARE THE WEDGE INFO WAS NOT INTERPRETED CORRECTLY RESULTING IN A TREATMENT ERROR. FOUR OF 10 FRACTIONS (30 GY PRESCRIBED DOSE) WERE DELIVERED WITHOUT THE WEDGE IN PLACE FOR ALL THE SEGMENTS FOR 2 OF THE 3 STEP AND SHOOT BEAMS. THE ERROR WAS DETECTED THROUGH PT-SPECIFIC DOSIMETRY. THE REMAINING TREATMENTS WERE WITHHELD. PT INJURY IS ESTIMATED BY THE USER FACILITY TO BE MILD. TOTAL DOSE DELIVERED TO TUMOR WAS APPROX 10% HIGHER THAN THE INTENDED DOSE. THE USER FACILITY REPORTED BASED ON THE LITERATURE, 1% TO 5% PROBABILITY OF COMPLICATION OF RADIATION MYELITIS EXISTS. THE ROOT CAUSE OF THIS INCIDENT IS USER ERROR. ADDITIONALLY, THE STANDARD TG-40 QA PRACTICES SHOULD HAVE DISCOVERED THIS ERROR. THE PINNACLE3 RTP SYSTEM PRODUCT ONLY ALLOWS THE USER TO DEVELOP RADIATION TREATMENT PLANS AND IS NOT A RADIATION THERAPY TREATMENT DEVICE ITSELF.

    Description of Event or Problem · 1

    ONE USER FACILITY REPORTED THAT A PT RECEIVING SPINAL IRRADIATION WAS TREATED WITH A PLAN, IN WHICH THE MOTORIZED WEDGE WAS NOT PROPERLY TRANSFERRED TO THE LINEAR ACCELERATOR. THE IMRT PLAN, CREATED IN PINNACLE3 CALLED FOR A MOTORIZED WEDGE ON TWO OF THREE BEAMS. WHEN THE PLAN WAS EXPORTED TO THE SITE'S IN-HOUSE DEVELOPED SOFTWARE, THE WEDGE WAS NOT INTERPRETED CORRECTLY, RESULTING IN A TREATMENT ERROR. USER FACILITY ESTIMATES CLINICAL CONSEQUENCES OF ERROR TO BE MILD. A 1% TO 5% PROBABILITY OF COMPLICATION OF RADIATION MYELITIS EXISTS. WHILE THIS EVENT OCCURRED IN 2008, IT WAS NOT COMMUNICATED TO PHILIPS THAT A POSSIBLE MISTREATMENT OCCURRED UNTIL THE FOLLOWING FIFTEEN DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM SYSTEM, PLANNING, RADIATION THERAPY MUJ PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 9200-0700C-ENG SOFTWARE VER. 8.0H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other