BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRACHYVISION

    MDR report key: 2585579 · Received May 17, 2012

    Report

    Report Number
    3003793371-2012-00004
    Event Type
    Other
    Date Received
    May 17, 2012
    Date of Event
    December 1, 2011
    Report Date
    May 17, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K102011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DATA ESTABLISHED THROUGH REFERENCES IN BRACHYVISION PRODUCT LABELING AND AAPM GUIDELINES THAT VERIFICATION OF THE PLANNED TREATMENT DISTANCES WITH THE DELIVERY TREATMENT DISTANCES IS A FUNDAMENTAL ASPECT OF QUALITY HDR BRACHYTHERAPY TREATMENT DELIVERY. BRACHYVISION PLAN REPORT OUTPUT INCLUDES ABSOLUTE VALUES FOR EACH DWELL POSITION IN THE PLAN ALONG THE TREATMENT LENGTH. THE END USERS WERE REQUIRED IN THIS CASE TO TRANSCRIBE THESE VALUES MANUALLY INTO THE TREATMENT CONSOLE PRIOR TO DELIVERY. IT IS THE CONCLUSION OF THIS INVESTIGATION THAT WHILE THE CHANGE IN LENGTH PARAMETERS BETWEEN SOFTWARE VERSIONS CONTRIBUTED TO THIS TREATMENT ERROR, THE PRIMARY AND ROOT CAUSE IS USER ERROR. SPECIFICALLY FAILURE TO VERIFY THE PLANNED VS TREATMENT DISTANCES PRIOR TO DELIVERY. THE DEVICE DID NOT MALFUNCTION, THIS WAS A USE ERROR. ((B)(4)).

    Description of Event or Problem · 1

    DWELL POSITIONS WERE DELIVERED INCORRECTLY TO A PT, 20 CM PROXIMAL TO THE INTENDED LOCATIONS AND OUTSIDE THE PT. THE TEAM WAS ACCUSTOMED TO A PARTICULAR DEFAULT 150.0 CM WHICH CORRESPONDED TO THEIR MEASURED APPLICATOR LUMEN LENGTH. THE VALUE FOR APPLICATOR LENGTH IN BRACHYVISION WAS CHANGED TO 130.0 CM AFTER A SOFTWARE UPGRADE. THE CLINICAL TEAM TRANSCRIBED THE INFO BY HAND DIRECTLY FROM THE TREATMENT PLAN PRINTOUT BASED ON A LUMEN LENGTH OF 130.0 CM, INTO THE TREATMENT DELIVERY CONSOLE, WITHOUT CONFIRMING THE PLANNED TREATMENT DISTANCES AGAINST THE PHYSICAL TREATMENT DISTANCES IN THE APPLICATOR AND TRANSFER TUBE. THE ADVERSE EVENT IS A MISADMINISTRATION WITH OVER 20% UNDER DOSE. THE PT WAS TREATED IN DECEMBER INTENDED FOR 5 FRACTIONS X 3.5 GY ONCE A WEEK. TWO FRACTIONS WERE TREATED CORRECTLY, AND 3 FRACTIONS WITH THE LENGTH ERROR. QUICKLY AFTER THE ERROR WAS DISCOVERED, IT WAS DETERMINED THAT THE PRIMARY DISEASE HAD ALREADY METASTASIZED TO OTHER AREAS IN THE BODY. THERE IS NO DISEASE PROGRESSION IN THE ENDOMETRIUM TO DATE, AND NO ACTIONS ARE PLANNED DUE TO THE DISTANT METASTASIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other