BEUDAMED
    FDA Adverse Event Other Summary report: N

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    MDR report key: 1196539 · Received October 14, 2008

    Report

    Report Number
    3004022368-2008-00004
    Event Type
    Other
    Date Received
    October 14, 2008
    Date of Event
    July 28, 2004
    Report Date
    October 13, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DUE TO INCORRECT CALIBRATION DOSE/MU FACTOR ENTERED BY COMPLAINANT SITE PHYSICS STAFF INTO PINNACLE3, A SYSTEMATIC ERROR LED TO MISTREATMENT (SYSTEMATIC 5% UNDER-DOSE) OF 869 PATIENTS BETWEEN 2004 AND 2006. NO PINNACLE3 DEFECT WAS ALLEGED OR OBSERVED. THE ROOT CAUSE OF THE INCIDENT WAS USE ERROR, WHEREBY INEXPERIENCED PHYSICS STAFF TOOK AN INCORRECT MEASUREMENT ON ONE TREATMENT MACHINE, ENTERED THE INCORRECT VALUE INTO THEIR PINNACLE3 TREATMENT PLANNING SYSTEM, AND USED IT TO COMPUTE PATIENT TREATMENTS FOR THAT SAME MACHINE. THEY APPARENTLY FAILED TO PERFORM ADEQUATE QUALITY ASSURANCE MEASURES THAT WOULD HAVE DETECTED THE ERROR (AS RECOMMENDED IN TG-40 AND STATED IN FRONT MATTER OF PINNACLE3 IFU DOCUMENTATION). THE ERROR WENT UNDETECTED FOR ONE YEAR. UPON DETECTION OF THE ERROR, IT WAS STILL NOT CORRECTED UNTIL ANOTHER FULL YEAR LATER. 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. (B) (4)

    Description of Event or Problem · 1

    ONE USER FACILITY REPORTED THAT AN INCORRECT CALIBRATION FACTOR LED TO AN ERROR IN DOSE DELIVERY. SYSTEMIC UNDER-DOSE OF 5% FOR ALL PATIENTS TREATED OCCURRED BETWEEN (B) (6) 2004 AND (B) (6) 2006. EIGHT HUNDRED AND SIXTY-NINE PATIENTS WERE INVOLVED. THE CORRECT CALIBRATED OUTPUT FACTOR HAD BEEN INITIALLY ENTERED IN THE SOFTWARE, BUT WAS LATER REPLACED BY AN INCORRECT FACTOR, DURING ANNUAL QA. THE ERROR WAS DETECTED ONE YEAR LATER, WAS REPORTED FOR THERAPY PLANNING SYSTEM, TPS, PINNACLE3 ADJUSTMENT, BUT ADJUSTMENT WAS NOT DONE. THE ERROR WAS THEN DETECTED ONE YEAR LATER DURING A SOFTWARE UPGRADE, WHEN MEDICAL PHYSICISTS FOUND THE CALIBRATED OUTPUT IN THE TPS PINNACLE3 TO BE INCONSISTENT WITH THE MEASURED OUTPUT. 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 9200-0613A-ENG SOFTWARE VER. 6. 2B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other