BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA

    MDR report key: 2018070 · Received March 8, 2011

    Report

    Report Number
    2916710-2011-00020
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    December 7, 2010
    Report Date
    February 8, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMBINATION OF ARIA 8.9 AND OBI 1.4 CAN LEAD TO THE DRR, KV AND MV IMAGES APPEARING AS COMPLETELY SHIFTED AND MISMATCHED, WHEN LOOKING AT THE ON-LINE MATCHING RESULT, IN OFF-LINE REVIEW. THE IMAGES APPEAR AS IF THEY WERE NOT MATCHED AT ALL, WHEN IN FACT MATCHING HAS BEEN DONE AND SAVED ON-LINE. THIS DISPLAY ISSUE IN OFF-LINE REVIEW CAN OCCUR WHEN THE REFERENCE IMAGES ARE IMPORTED FROM A THIRD PARTY TREATMENT PLANNING SYSTEM, WHEN THE PLAN AND IMAGES DO NOT CONTAIN PATIENT POSITION INFORMATION. THE REFERENCE IMAGES HAVE ISOCENTER INFORMATION, BUT THIS INFORMATION IS NOT EXPORTED DUE TO THE MISSING PATIENT ORIENTATION IN THE IMAGE SERIES. THE DISPLAY OF THE IMAGES IN OFF-LINE REVIEW CAN MISLEAD THE USER AND UNNECESSARY SHIFTS FROM THE CORRECT ISOCENTER POSITION CAN OCCUR. THE INCORRECT SHIFT WHICH IS DISPLAYED IN OFFLINE REVIEW OCCURS IF FOLLOWING CRITERIA IS MET: IMPORTED PLAN DOES NOT CONTAIN PATIENT POSITION, AND IMPORTED REFERENCE IMAGES DO NOT CONTAIN PATIENT POSITION, BUT CONTAIN ISOCENTER INFORMATION OTHER THAN 0.0/0.0/0.0, AND DICOM DATA IS IMPORTED INTO ARIA 8.9, AND IMAGES ARE SET AS REFERENCE IMAGES BEFORE DEFINING THE PATIENT ORIENTATION IN THE PLAN, AND NO PLAN REVISION OR PLAN COPY IS DONE, AND OBI 1.4 OR OBI 1.5 WITH WRONG IMPLEMENTATION UID CONFIGURATION IS USED. THOUGH PROBABILITY OF HARM RESULTING FROM THIS ISSUE HAS BEEN DETERMINED TO BE REMOTE, A CUSTOMER TECHNICAL BULLETIN (CTB) WILL BE SENT TO ALL AFFECTED CUSTOMERS. ALL CORRECTIVE ACTIONS WILL BE HANDLED VIA VARIAN'S CAPA PROCESS. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    PATIENT IS LOADED ON THE OBI WORKSTATION. ON-LINE MATCHING IS DONE WITHOUT ANY PROBLEM. WHEN OPENING THE PATIENT IN OLR (OFF-LINE REVIEW), THE DRR AND KV IMAGES APPEAR AS COMPLETELY SHIFTED; WHEN LOOKING AT THE ON-LINE MATCHING RESULT, THE IMAGES APPEAR AS IF THEY WERE NOT MATCHED AT ALL WHEREAS MATCHING HAS BEEN DONE AND SAVED ON-LINE. THERE WAS NO PATIENT INJURY OR MISADMINISTRATION REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. HIT

    Patients

    Seq Age Sex Outcome Treatment
    1