BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4DITC

    MDR report key: 1991334 · Received January 26, 2011

    Report

    Report Number
    2916710-2010-00168
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC, ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SEQUENCE OF EVENTS WAS REPORTED TO BE AS FOLLOWS: PT ID (B)(4) OPENED INSTEAD AND SHOWED THAT THEY WOULD BE TREATING FRACTION 4. RADIATION THERAPISTS CLOSED PT AT THIS POINT AND REPORTED PROBLEM. IT WAS CLARIFIED THAT THE RTTS DID NOT CREATE ANOTHER APT IN TIME PLANNER. IT WAS CLARIFIED THAT THE APT WAS IN COMPLETED STATUS. SCREENSHOT OF APT HISTORY WAS CAPTURED. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PREVIOUSLY TREATED PATIENT'S TREATMENT PLAN, RE-LOADED AT THE 4DITC FOR TREATMENT OF THE NEXT PATIENT. PATIENT ID (B)(4) WAS TREATED ON (B)(6) 2010 AT 10:34 AM. THE CUSTOMER COMPLETED A TREATMENT ON THE 21EX UNIT WITH OBI AND ARIA RUNNING V8.6. ONLY ONE OTHER PATIENT WAS CHECKED IN AND AS SUCH, THE NEW PATIENT WAS HIGHLIGHTED ON THE PATIENT LIST AT THE 4DITC STATION; THE THERAPIST CLICKED "OKAY" AND THE PATIENT THAT WAS JUST TREATED LOADED ON THE WORKSTATION AND INDICATED IT WAS ON THE NEXT FRACTION (FX 4; FX 3 HAD JUST BEEN DELIVERED). TYPICALLY YOU CANNOT SELECT A PATIENT THAT WAS ALREADY COMPLETED. THE CUSTOMER DID NOT ATTEMPT TO MODEUP TO TEST IF THE DOSIMETRY LIMITS WOULD HAVE PREVENTED THE TREATMENT. NO INJURY OR MISADMINISTRATION WAS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 2

    THE SEQUENCE OF EVENTS WAS REPORTED TO BE AS FOLLOWS: RADIATION THERAPISTS CLOSED PT AT THIS POINT AND REPORTED PROBLEM. IT WAS CLARIFIED THAT THE RTTS DID NOT CREATE ANOTHER APT IN TIME PLANNER. IT WAS CLARIFIED THAT THE APT WAS IN COMPLETED STATUS. SCREENSHOT OF APT HISTORY WAS CAPTURED. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION OF THE DEVICE MAY HAVE OCCURRED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 2

    A PREVIOUSLY TREATED PATIENT'S TREATMENT PLAN, RE-LOADED AT THE 4DITC FOR TREATMENT OF THE NEXT PATIENT. PATIENT ID (B)(4) WAS HIGHLIGHTED AND MODE UP ON THE 4DITC BETWEEN 10:34AM AND 10:49AM. THE CUSTOMER COMPLETED A TREATMENT ON THE 21EX UNIT WITH OBI AND ARIA RUNNING V8.6. ONLY ONE OTHER PATIENT WAS CHECKED IN AND AS SUCH, THE NEW PATIENT WAS HIGHLIGHTED ON THE PATIENT LIST AT THE 4DITC STATION; THE THERAPIST CLICKED "OKAY" AND THE PATIENT THAT WAS JUST TREATED LOADED ON THE WORKSTATION AND INDICATED IT WAS ON THE NEXT FRACTION (FX 4; FX 3 HAD JUST BEEN DELIVERED). TYPICALLY YOU CANNOT SELECT A PATIENT THAT WAS ALREADY COMPLETED. THE CUSTOMER DID NOT ATTEMPT TO MODEUP TO TEST IF THE DOSIMETRY LIMITS WOULD HAVE PREVENTED THE TREATMENT. NO INJURY OR MISADMINISTRATION WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4DITC DELIVERY SYSTEMS IYE VARIAN MEDICAL SYSTEMS INC, ONCOLOGY SYSTEMS H51

    Patients

    Seq Age Sex Outcome Treatment
    1
    2