BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMX/GENERAL

    MDR report key: 2011908 · Received February 28, 2011

    Report

    Report Number
    9611894-2011-00001
    Event Type
    Other
    Date Received
    February 28, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    NUCLETRON BV
    Product Code
    KPQ
    PMA / PMN Number
    K946128
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN EXPORTING PLAN DATA TO AN RTP LINK FILE, ONCENTRA SIMULATION IS DESIGNED IN SUCH A WAY THAT ONLY EXPORT PLAN DATA WHICH IS SUPPORTED BY THE SIMULATOR IS TRANSFERRED. INFO ON THIS IS STATED IN THE ONCENTRA SIMULATION USER MANUAL ((B)(4)). TREATMENT PLAN DATA WHICH IS NOT SUPPORTED BY THE SIMULATOR IS NOT EXPORTED TO RTP LINK. THIS INCLUDES DOSE VALUES, MUS, WEDGES, BOLUS AND COMPENSATORS. THESE ITEMS ARE LEFT OUT WHICH REQUIRE THE USER TO VERIFY CORRECT INPUT OF ALL PARAMETERS INTO OTHER SYSTEMS USING THE APPROVED TREATMENT PLAN. THE VALUES THAT ARE BEING LEFT OUT IS A PRECAUTION MEASURE AND SAFETY FEATURE TO AVOID THAT THE TRANSFERRED DATA IS USED FOR TREATMENT DELIVERY WITHOUT ANY FURTHER VERIFICATION. THE TYPICAL NEXT STEP IN THE WORKFLOW WOULD BE TO SEND THE PLAN BACK TO A TREATMENT PLANNING SYSTEM TO RECALCULATE THE DOSE VALUES AND NEEDED BEAM LIMITING ACCESSORIES. A CUSTOMER INFO BULLETIN (CIB) HAS BEEN CREATED AND DISTRIBUTED TO ALL ONCENTRA SIMULATION CUSTOMERS WORLDWIDE.

    Description of Event or Problem · 1

    THE CUSTOMER EXPORTED A TREATMENT PLAN WITH WEDGES IN THE BEAMS TO ONCENTRA SIMULATION (OCS). DURING THE SIMULATION, THE CUSTOMER DECIDED TO MAKE SOME BEAMS A LITTLE LONGER SO HE MADE A COPY OF THE PLAN. WHILE IN THIS STATUS, NOT IN THE MODUS VERIFICATION ANYMORE AS REAL SIMULATION, HE SIMULATED THE PT AND MADE SOME CHANGES FOR SOME BEAMS. AFTER THE SIMULATION, HE EXPORTED THE PLAN FROM OCS 2.4 TO LANTIS VIA RTP LINK. AT LANTIS, HE IMPORTED THE PLAN AND SAW THAT THE MU'S WERE 0 FOR ALL BEAMS. THE CUSTOMER THEN ENTERED THE MU'S MANUALLY, BUT WAS NOT AWARE THAT THE WEDGES OF THE BEAMS WERE NOT IN ANYMORE AND NO LONGER PART OF THE TREATMENT PLAN. HE TREATED THE PT WITH THE SAME COUNT OF MU BUT AS AN OPEN FIELD WITHOUT THE WEDGE FOR THE BEAMS. A MISTREATMENT TOOK PLACE. THE PT WAS PLANNED FOR 20 FRACTIONS OF 2 GY EACH. HE RECEIVED 10 FRACTIONS IN TOTAL OF 60 GY. WHEN THIS WAS DETECTED, THE RADIOTHERAPY SESSION WAS CANCELLED AND THE TREATMENT NOT FINALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMX/GENERAL ONCENTRA SIMULATION KPQ NUCLETRON BV 114670A01-01

    Patients

    Seq Age Sex Outcome Treatment
    1