BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIVANTAGE DH

    MDR report key: 823237 · Received March 1, 2007

    Report

    Report Number
    1518293-2007-00005
    Event Type
    Other
    Date Received
    March 1, 2007
    Report Date
    February 2, 2007
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INJECTOR WAS EVALUATED BY THE PRODUCT ENGINEERING. FINDINGS ARE AS FOLLOWS: THE FIRST THING DONE WAS TO REVIEW THE SHOT HISTORY OF THE INJECTOR. INSIDE THE HISTORY FILE, NUMEROUS INJECTIONS WITH FLOW RATES OF 2.0ML/SEC OR LOWER WERE FOUND. THERE WAS ONE INJECTOR THAT INDICATED A 7.5ML/SEC FLOW RATE WHICH IS BELIEVED TO BE THE SHOT IN QUESTION ON THE COMPLAINT. THE HISTORY INDICATES (ON 1/3/07) THAT THE 7.5ML/SEC FLOW RATE WAS PROGRAMMED AND RUN FOR A VOLUME OF 16ML. AT THAT TIME, THE INJECTION STOPPED VIA OPERATOR INTERACTION OR INJECTOR STALLING. THE COMPLAINT INDICATES THAT IT STALLED AND, ALTHOUGH IT IS NOT KNOWN THE RESTRICTION THAT THEY WERE RUNNING THROUGH, IT WOULD BE ASSUMED IT DID BASED ON THE 7.5ML/SEC FLOW RATE. THERE WERE 9 VARIOUS INJECTIONS (ALL AT OR BELOW 2.0ML/SEC) RUN ON THIS INJECTOR ON FEBRUARY 2ND AND 3RD. THESE WERE PERFORMED BY FIELD SERVICE ENGINEER (OUR FIELD SERVICE TECHNICIAN) IN AN ATTEMPT TO REPEAT THE FAILURE. INTERNALLY HERE, WE CHECKED THE RESULTS HISTORY AS WELL AS RUNNING 3 MORE SHOTS AT LOW FLOW RATES AND COULD NOT DUPLICATE THE FAILURE. IN CONCLUSION, IT SEEMS THAT THE INJECTOR RAN THE PROGRAMMED SHOT OF 7.5ML/SEC FOR A LENGTH OF 16MM UPON WHICH THE INJECTOR STALLED BASED ON TOO HIGH A FLOW FOR THE RESTRICTION USED. THE HISTORY FILE INDICATES THAT THIS WAS THE PROGRAMMED FLOW. THERE IS NO EVIDENCE OF THE INJECTOR RUNNING A DIFFERENT FLOW RATE (7.5) THAN CUSTOMER INDICATES PROGRAMMING (1.5).

    Description of Event or Problem · 1

    LF TECHNICAL SUPPORT REPORTS VIA FAX THAT CUSTOMER STATES; "PROTOCOL WAS SET TO DELIVER 1.5CC PER SECOND. UPON START OF INJECTION RATE JUMPED TO 7.5CC PER SECOND. 2/2: CUSTOMER STATES THAT NURSE SET THE PROTOCOL MANUALLY ON THE CONSOLE BEFORE SHE WENT INTO THE CT SUITE TO START THE IV. ONCE IV WAS STARTED & CONNECTED TO THE INJECTOR SYSTEM, SHE ASKED THE TECHNOLOGIST IN THE CT CONTROL ROOM IF SHE COULD START THE INJECTION. TECHNOLOGIST ACKNOWLEDGED. THE NURSE STARTED THE INJECTION. NURSE IMMEDIATELY REALIZED BY THE SOUND THAT SOMETHING WAS WRONG AND WHEN SHE LOOKED BACK AT THE POWERHEAD, SHE SAW THE RATE WAS 7.5. THE SYSTEM STALLED AT THAT TIME, SO THE INJECTION WAS NOT TOTALLY COMPLETED. SYSTEM RESET AND PROCEDURE COMPLETED WITHOUT ANY FURTHER INCIDENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIVANTAGE DH CT POWER INJECTOR SYSTEM IZO LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other