BEUDAMED
    FDA Adverse Event Other Summary report: N

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    MDR report key: 1172678 · Received September 13, 2008

    Report

    Report Number
    3004022368-2008-00003
    Event Type
    Other
    Date Received
    September 13, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 11, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ROOT CAUSE OF THIS INCIDENT HAS BEEN DETERMINED TO BE USER ERROR. THE STANDARD QA PRACTICES SHOULD HAVE DISCOVERED THIS ERROR. ADDITIONALLY, NO PRODUCT MALFUNCTION HAS OCCURRED. THE USER FACILITY DOES NOT ALLEGE ANY DEVICE DEFECT OR MALFUNCTION. THE PINNACLE3 PRODUCT AND LABELING WERE EVALUATED, AND IT WAS DETERMINED THE DEVICE PERFORMED AS INTENDED. THE CUSTOMER CREATED A HEAD AND NECK IMRT PLAN. THE POI USED AS THE ISOCENTER FOR THE SETUP DRRS WITH THE CURRENT POI. PINNACLE USES THE CURRENT POI AS ISOCENTER FOR DRRS BY DEFAULT. IN THIS CASE, THE ISOCENTER WAS THE CALCULATION POINT, WHICH WAS 6CM SUPERIOR TO THE DESIRED ISOCENTER. A RASH WAS NOTICED ON THE PT'S FACE AND ORIGINALLY THOUGHT TO BE RELATED TO THE CHEMOTHERAPY TAKING PLACE CONCURRENTLY WITH THE RADIATION TREATMENT. WHEN THE RASH DID NOT RESPOND TO TREATMENT, THE PLAN WAS FURTHER EXAMINED AND THE ERROR WAS DISCOVERED. THE PT'S OPTIC NERVE RECEIVED 6576 CGY VERSUS PLANNED 296 CGY. THE PT IS CURRENTLY SUFFERING EYE IRRITATION. THE LONG TERM EFFECTS ARE UNK. THE PINNACLE3 RADIATION THERAPY PLANNING SYSTEM PRODUCT ONLY ALLOWS THE USER TO DEVELOP RADIATION TREATMENT PLANS AND IS NOT A RADIATION THERAPY TREATMENT DEVICE ITSELF. THE PINNACLE3 PRODUCT PERFORMED AS INTENDED. THERE WERE NO PRODUCT MALFUNCTIONS ASSOCIATED WITH THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CREATED A HEAD AND NECK IMRT PLAN. THE POI (POINT OF INTEREST) USED AS THE ISOCENTER FOR THE SETUP DRRS WITH THE CURRENT POI. PINNACLE3 USES THE CURRENT POI AS ISOCENTER FOR DRRS BY DEFAULT. IN THIS CASE, THE ISOCENTER WAS THE CALCULATION POINT, WHICH WAS 6CM SUPERIOR TO THE DESIRED ISOCENTER. A RASH WAS NOTICED ON THE PT'S FACE AND ORIGINALLY THOUGHT TO BE RELATED TO THE CHEMOTHERAPY TAKING PLACE CONCURRENTLY WITH THE RADIATION TREATMENT. WHEN THE RASH DID NOT RESPOND TO TREATMENT, THE PLAN WAS FURTHER EXAMINED AND THE ERROR WAS DISCOVERED. THE PT'S OPTIC NERVE RECEIVED 6576 CGY VERSUS PLANNED 296 CGY. THE PT IS CURRENTLY SUFFERING EYE IRRITATION. THE LONG TERM EFFECTS ARE UNK. NO PRODUCT MALFUNCTION HAS BEEN ALLEGED.

    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. 453560461331 SOFTWARE VER. 8.0M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other