BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTRAST INJECTION HIGH PRESSURE TUBING

    MDR report key: 4151070 · Received September 29, 2014

    Report

    Report Number
    4151070
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    June 11, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    MALE PRE-SCHOOLER WITH HISTORY OF HYPOPLASTIC LEFT HEART SYNDROME DIAGNOSED IN UTERO, WITH CORONARY ARTERY TO LEFT VENTRICULAR FISTULAE. HE HAD UNDERGONE MULTIPLE CARDIAC SURGERIES INCLUDING COIL CLOSURE OF THE FISTULAE, NORWOOD/SANO PROCEDURES, BIDIRECTIONAL GLENN PROCEDURE WITH BANDING OF THE RIGHT VENTRICLE TO PULMONARY ARTERY CONDUIT, ATRIAL SEPTECTOMY AND TRICUSPID VALVE REPAIR FOR TRICUSPID REGURGITATION. THE PATIENT WAS UNDERGOING A RIGHT AND LEFT HEART CATHETERIZATION PROCEDURE WITH ANGIOGRAPHY AND POSSIBLE COIL EMBOLIZATION OF SIGNIFICANT VENOVENOUS OR AORTOPULMONARY COLLATERAL VESSELS. THE HIGH-PRESSURE IV TUBING WAS HOOKED UP TO THE POWER-INJECTOR PUMP SYSTEM TO DELIVER THE DYE SOLUTION FOR ANGIOGRAPHY; THE PUMP REACHED 852 PSI WHEN THE TUBING FRACTURED AT THE LUER-LOCK CONNECTION TO THE PATIENT'S IV LINE. THE LUER LOCK ASSEMBLY CAME APART FROM THE BASE. A SECOND SET OF TUBING WAS PREPARED, AND WHEN INFUSION WAS STARTED, IT REACHED 677 PSI WHEN THE LUER CONNECTOR CAME APART AT THE SAME PLACE. TUBING IS LISTED AS CAPABLE OF ADMINISTERING UP TO 1200 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605253 CONTRAST INJECTION HIGH PRESSURE TUBING DISPLAY, CATHODE-RAY TUBE, MEDICAL, HIGH PRESSURE TUBING DXJ MERIT MEDICAL SYSTEMS, INC. 48" 1200 PSI H427832
    605399 CONTRAST INJECTION HIGH PRESSURE TUBING DISPLAY, CATHODE-RAY TUBE, MEDICAL, HIGH PRESSURE TUBING DXJ MERIT MEDICAL SYSTEMS, INC. 48" 1200 PSI H379160

    Patients

    Seq Age Sex Outcome Treatment
    1 46 MO OF DYE SOLUTION.| NO OTHER THERAPIES| THE TUBING WAS FOR HIGH-PRESSURE ADMINISTRATION| PATIENT WAS HAVING A HEART CATHETERIZATION, AND