BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUENCER

    MDR report key: 643141 · Received October 26, 2005

    Report

    Report Number
    2950347-2005-00001
    Event Type
    Injury
    Date Received
    October 26, 2005
    Date of Event
    May 10, 2005
    Report Date
    October 25, 2005
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TOW OUT OF SEVEN SCHEDULED RADIATION THERAPY TREATMENTS FOR THE AFFECTED PT WERE PERFORMED WITH THE POSTERIOR FIELD X COLLIMATOR LEAF POSITIONS REVERSED. THIS RESULTED IN AN UNDER-DOSE ON THE LEFT AND AN UNINTENDED EXPOSURE OF A 5.2 CENTIMETER STRIP ON THE RIGHT OF THE INTENDED CANCER TREATMENT FIELD. THE TREATMENT FIELDS WERE CORRECTLY DEFINED IN IMPAC'S SEQUENCER VERIFY AND RECORD SYSTEM. PRIOR TO THE SIXTH TREATMENT, THE POSTERIOR FIELD WAS MODIFIED, RENDERING AN INCORRECT LEAF PLAN. THE TREATMENT FIELDS WERE DELIVERED WITH THE DEFINED PARAMETERS. IMPAC CANNOT CONCLUSIVELY IDENTIFY THE EXACT STEPS THAT THE USER PERFORMED OR WHY THE USER REVERSED THE FIELD; HOWEVER, TREATMENT DATA DOES SHOW THAT, WITHIN THE SEQUENCER PRODUCT, THE USER MODIFIED THE TREATMENT FIELD (FLIPPED THE PARTICULAR FIELD) AND APPROVED THE MODIFICATION PRIOR TO TREATMENT. WHEN THE FIELD WAS SELECTED FOR THE TREATMENT, THE USER WAS INFORMED THAT THE FIELD HAD BEEN CHANGED AND PRESENTED WITH WHAT WAS CHANGED. THE USER CONTINUED AND TREATED THE FIELD ACCORDING TO THAT MODIFIED PLAN (WITH THE FLIPPED POSTERIOR FIELD LEAF POSITIONS) FOR TWO TREATMENTS. DESPITE THE REQUIREMENT TO APPROVE THE MODIFIED TREATMENT FIELD AND THE DISPLAY OF TWO ADDITIONAL WARNINGS ABOUT THE CHANGE, THE USER MISTAKENLY FLIPPED THE FIELD AND DELIVERED THE TREATMENT ACCORDING TO THE USER REVISED TREATMENT PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENCER RECORD AND VERIFY SYSTEM KPQ IMPAC MEDICAL SYSTEMS, INC. 18.0.1.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other