BEUDAMED
    FDA Adverse Event Other Summary report: N

    HI-ART SYSTEM

    MDR report key: 1530973 · Received October 20, 2009

    Report

    Report Number
    3003873069-2009-00008
    Event Type
    Other
    Date Received
    October 20, 2009
    Date of Event
    September 21, 2009
    Report Date
    October 20, 2009
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K060912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION TO BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO (B) (6), MEDICAL PHYSICIST FROM (B) (6) - (B) (4); DUE TO A SERIES OF INTERNAL MISCOMMUNICATIONS, THE THERAPISTS WERE NOT APPROPRIATELY APPRISED OF A CHANGE IN PROTOCOL WHICH LEAD TO THE PT RECEIVING THE FULL TREATMENT DOSE - 4800 CGY IN ONE DAY, INSTEAD OF A 1200 CGY DAILY DOSE FOR 4 DAYS. THE THERAPIST PREVIOUSLY TREATED SBRT PTS WITH HYPO FRACTIONATED PLANS BY DELIVERING MULTIPLE FRACTIONS ON THE SAME DAY BECAUSE, THEY HAD THE MISUNDERSTANDING THAT OUR SYSTEM COULD NOT DELIVER 1200 CGY IN ONE FRACTION, THIS WAS THEIR PROTOCOL. FOR THIS PT THEY DID NOT FOLLOW THE PREVIOUS PROTOCOL WHICH USED HYPO FRACTIONATED PLANS. INSTEAD THEY CREATED A PLAN WHICH ALLOW THE THERAPIST TO DELIVER THE FULL DAILY DOSE, IN THIS CASE 1200 CGY, IN ONE FRACTION RATHER THAN MULTIPLE FRACTIONS IN ONE DAY. (B) (6) DID NOT REPORT PT INJURY. HE SAID THE PTS DISEASE MORPHOLOGY WAS SUCH THAT THE TREATMENT REGIONS WERE VERY FAR FROM THE SPINAL CORD, AND HAD A MINIMAL IMPACT UPON THE LUNGS. HE FURTHER SAID, THE ISSUE IS AN INTERNAL ONE TO THE CLINIC; THE TOMO PLANNING SYSTEM AND MACHINE PERFORMED EXACTLY AS PLANNED AND INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-ART SYSTEM IYE AND MUJ IYE TOMOTHERAPY INCORPORATED H-0000-0003

    Patients

    Seq Age Sex Outcome Treatment
    1