BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR LE, INJ SYS, PRGM SALE

    MDR report key: 1211882 · Received October 23, 2008

    Report

    Report Number
    1518293-2008-00316
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING INVESTIGATION PENDING. UPON RECEIPT OF THE INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DURING APPLICATIONS TRAINING, THE CUSTOMER DECIDED TO USE THE INJECTOR FOR A BREAST PROCEDURE. INJECTOR PROTOCOL WAS SET WITH THE FOLLOWING; DRIP MODE, .2ML SALINE DRIP FOR ONE HOUR TIME SPAN, INJECTION PHASE A, 3ML/SEC FOR 20ML VOLUME CONTRAST, INJECTION PHASE B, 3ML/SEC FOR 20ML VOLUME. CUSTOMER NOTED THAT WHILE IN THE DRIP MODE, THE RATE CHANGED FROM .2ML/SEC TO 3.0ML/SEC. THE DRIP MODE WAS STOPPED. THE INJECTION PROTOCOL WAS ENABLED AND STARTED, AND COMPLETED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISTAR LE, INJ SYS, PRGM SALE MRI POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. OPTISTAR LE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK