BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE SERIES LINAC

    MDR report key: 5652840 · Received May 13, 2016

    Report

    Report Number
    9617016-2016-00004
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Report Date
    May 13, 2016
    Manufacturer
    ELEKTA LTD
    Product Code
    IYE
    PMA / PMN Number
    K 051932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK ASSESSMENT CONCLUDED AS FOLLOWS: SEVERITY: IF UNNOTICED, A SHIFT PERFORMED TWICE COULD PUT AN ORGAN-AT-RISK IN THE PATH OF THE MV BEAM, AND POTENTIALLY RESULT IN DEATH OR SEVERE INJURY. (MAJOR). LIKELIHOOD: THE INITIATING EVENT IS HUMAN ERROR, THE LIKELIHOOD PROBABLE. THE WORKFLOW IS UNUSUAL, TO RESULT IN HARM, THE USER MUST: CHOOSE TO RESEND THE MOVE WHEN THERE IS A VISUAL INDICATOR ON THE CMA ACTIVATION THAT THE RESULTS HAVE BEEN RECEIVED BY MSQ AND MOVE THE PATIENT USING THE ASU BUTTONS EVEN THOUGH THIS TASK WILL HAVE BEEN RECENTLY COMPLETED.

    Description of Event or Problem · 1

    WHEN XVI REGISTRATION RESULTS WERE SENT TO MOSAIQ (MSQ), AN ERROR APPEARED ON XVI STATING MSQ HAD NOT RECEIVED THE REGISTRATION RESULTS. THE CUSTOMER HAD ALREADY SHIFTED THE PATIENT BUT AS THEY WANTED TO RECORD THE SHIFT, A RETRY WAS ATTEMPTED, WHICH CAUSED THE PATIENT TO BE MOVED OFF TARGET. DUE TO THIS XVI WAS RE-SCANNED AND THE PATIENT SHIFTED BACK TO THE CORRECT TREATMENT POSITION. ANALYSIS OF THE MSMQ LOGS ON THE SEQUENCER AND XVI FOR THE AFFECTED PATIENT CONFIRMED THAT THE ISSUE OCCURRED DUE TO AN MSMQ EXCEPTION LOGGED ON XVI. THIS INDICATES THERE WAS A FAULT IN THE WINDOWS MESSAGING QUEUING SERVICE ON THE XVI WORKSTATION. THE LOGS SHOW AN ERROR WHEN XVI TRIED TO SEND THE ACQUISITION COMPLETE MESSAGE TO MSQ, THE MESSAGE WAS RECEIVED BY MSQ PROCESSED AND A RESPONSE SENT TO XVI, HOWEVER THE RESPONSE MESSAGE WAS NOT PROCESSED ON THE XVI SIDE. THE MSQ AND XVI APPLICATIONS BEHAVED AS TO BE EXPECTED IN THIS CIRCUMSTANCE. THE COUCH MOVE ASSISTANT (CMA) DISPLAYED IN MSQ WITH THE SHIFTS. XVI WAS UNAWARE THAT THE SHIFTS HAD BEEN RECEIVED BY MSQ AND DISPLAYED THE WARNING WITH THE PROMPT TO CANCEL OR RETRY SENDING THE SHIFTS. INITIAL INVESTIGATION HIGHLIGHTS THE 'RETRY' MESSAGE IS NOT APPLICABLE TO THIS PARTICULAR FAILURE MODE AND COULD BE CONFUSING TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310071 PRECISE SERIES LINAC ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD 13271-007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other