BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1625245 · Received February 25, 2010

    Report

    Report Number
    8020711-2010-00002
    Event Type
    Malfunction
    Date Received
    February 25, 2010
    Date of Event
    January 28, 2010
    Report Date
    January 28, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KPQ
    PMA / PMN Number
    K033339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFO, VARIAN HAS BEEN ABLE TO CONFIRM THE USER'S ALLEGATION: FOLLOWING PLAN CREATION AT ACUITY, AN IMAGE IS ACQUIRED AND GRABBED TO CREATE A FIELD FROM PT ANTERIOR TO POSTERIOR (E.G AP FIELD, AP IMAGE). AN OUTLINE IS DRAWN ON THE ACQUIRED IMAGE BY THE PHYSICIAN, OUTLINING THE AREAS TO BE TREATED. THE MULTI LEAF COLLIMATOR IS ADDED AND FITTED TO THIS OUTLINE. IF THE USER CREATES AN OPPOSING FIELD (PA FIELD, PA IMAGE), THE MLC ARE NOT CORRECTLY OPPOSED (THE MLC ON THE PA FIELD ARE POSITIONED EXACTLY AS ON THE AP FIELD RATHER THAN IN A MIRRORED POSITION). IF THE USER DOESN'T NOTICE THE INCORRECT PLACEMENT OF THE MLC ON THE OPPOSED FIELD AND IF IT ISN'T CAUGHT DURING PLAN REVIEW OR APPROVAL FOR TREATMENT, THE PT CAN BE TREATED WITH INCORRECTLY PLACED MLC ON THE OPPOSED FIELD. IT IS STANDARD CLINICAL PRACTICE TO ACQUIRE PORTAL IMAGES ON THE FIRST DAY OF TREATMENT. THESE IMAGE ARE REVIEWED AND APPROVED BY THE PHYSICIAN PRIOR TO STARTING TREATMENT FOR SINGLE FRACTION TREATMENTS AND TYPICALLY BEFORE THE SECOND FRACTION FOR MULTIPLE FRACTION COURSES. ANY MISPLACEMENT OF THE MLC SHOULD BE IDENTIFIED PRIOR TO TREATMENT, AND IF NOT THEN DURING PHYSICIAN IMAGE REVIEW FOLLOWING THE FIRST TREATMENT FRACTION. THUS, THE PT WOULD LIKELY BE TREATED FOR AT MOST A SINGLE FRACTION WITH INCORRECT MLC. THIS PROBLEM HAS BEEN DETERMINED TO BE ISOLATED TO THE LATEST (CURRENT) RELEASE OF THE SOFTWARE. ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT ON TWO SEPARATE OCCASIONS DURING TREATMENT PLANNING CREATION IN ACUITY, THE MULTI LEAF COLLIMATOR SHAPE FOR A BEAM CREATED USING THE COPY AND OPPOSE BEAM FUNCTION IS MIRRORED ON THE X-AXIS, INSTEAD OF THE Y-AXIS. NO SERIOUS INJURY TO THE PT WAS REPORTED, AS THIS EVENT WAS OBSERVED BY THE USER DURING TREATMENT PLANNING, AND THE PLAN WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY SIMULATOR KPQ VARIAN MEDICAL SYSTEMS H77-SIM

    Patients

    Seq Age Sex Outcome Treatment
    1