BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 2020445 · Received February 8, 2011

    Report

    Report Number
    1518293-2011-00012
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR BELIEVES THE ISSUE IS WITH THE SYRINGE AND NOT THE INJECTOR, SO THEY DO NOT WANT A FIELD SERVICE ENGINEER VISIT. NO ONE WAS HARMED DURING THIS INCIDENT. OPERATORS REPORT THERE IS NO SIGN OF A INJECTOR MALFUNCTION. SYSTEM CONTINUALLY IN USE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THERE WERE NO PROBLEMS NOTED WITH THE INJECTOR HOME SEQUENCE, SYRINGE LOAD OR ENABLE. A SIDE INJECTION ONLY. FLOW RATE PROGRAMMED TO STARTED AT 1.5CC/SEC AND INCREASE TO 3.0CC/SEC; LF COILED TUBING WITH DIRECT CONNECTION TO IV WITH HEPLOCK. THROUGHOUT THE INJECTION, THE PT BENT HIS ARM AT LEAST TWICE TRIGGERING A PRESSURE LIMIT WARNING. AFTER ABOUT 80CC HAD BEEN INJECTED, THE SYRINGE FAILED AT THE FLANGE AND FLEW TO THE FLOOR. TECHNOLOGIST VERIFIED NO INJURY; SCAN COMPLETED AS ENOUGH CONTRAST HAD BEEN ADMINISTERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR