BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRACHYVISION

    MDR report key: 2022176 · Received March 11, 2011

    Report

    Report Number
    3003793371-2011-00005
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    VARIAN MEDICAL
    Product Code
    MUJ
    PMA / PMN Number
    K992762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CREATED A TEST PT TO REPRODUCE THE PROBLEM AND IT WAS RE-PRODUCIBLE. THEY TRIED TO EXPORT THE PLAN DIRECTLY FROM BRACHYVISION TO SEE IF IT WAS POSSIBLE AND COULD NOT, THE PLAN FAILED. PROTOCOL WAS 1 FRACTION - 10GY, BRACHYVISION 8.6.15, CONSOLE 1.1.0 (BUILD 2490), FIRMWARE B126. ALTHOUGH THERE WAS NO SERIOUS INJURY REPORTED IN THIS CASE, THE AVAILABLE INFO SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SEVERAL APPLICATOR CHANNELS SHIFTED DUE TO DELETING AND DEACTIVATING APPLICATORS IN BV 8.6. THE CUSTOMER WAS PERFORMING A PROSTATE CASE WITH 25 IMPLANTED NEEDLES. THEY CREATED A PLAN WITH 25 APPLICATORS, LEAVING THE 25TH APPLICATOR EMPTY (NO NAME NO CHANNEL NUMBER) THEY WERE CERTAIN THEY WOULD ELIMINATE ONE NEEDLE TO USE ONLY 24 CHANNELS AT THE END BUT DID NOT KNOW AT THE BEGINNING WHICH ONE WOULD NOT BE USED. THEY DID THE PLAN WITH THE 24 CHANNELS THEN REALIZED THAT THEY DIDN'T NEED NEEDLE 10; THEY DELETED NEEDLE 10 AND RENAMED APPLICATOR 25 TO APPLICATOR 10 CHANNEL 10. THEY SAVED - PLAN APPROVE - TREATMENT APPROVE - NO ERRORS. THE PLAN WAS LOADED ON IX VIA ARIA AND CHECKED IF TOTAL TIME WAS THE SAME - (YES), SO THEY TREATED. AT THE END OF THE TREATMENT, THEY REALIZED THAT, STARTING FROM CHANNEL 10, ALL CHANNELS WERE SHIFTED, MEANING THE DWELL POSITONS-TIMES OF CHANNEL 11 WAS DELIVERED TO CHANNEL 10, DWELL-TIME OF CHANNEL 12 DELIVERED TO CHANNEL 11... AND DWELL OF CHANNEL 25TH DELIVERED TO CHANNEL 24TH. THE CUSTOMER SENT A REPORT STATING THEY WILL NOW EVALUATE THE DOSE DELIVERED COMPARED TO THE DOSE PLANNED. THE PLAN IN BRACHYVISION DOES NOT SHOW ANY ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRACHYVISION SYSTEM, PLANNING, RADIATION THERAPY TREAT MUJ VARIAN MEDICAL H48

    Patients

    Seq Age Sex Outcome Treatment
    1