BEUDAMED
    FDA Adverse Event Death Summary report: N

    SORIN

    MDR report key: 8252696 · Received January 16, 2019

    Report

    Report Number
    8252696
    Event Type
    Death
    Date Received
    January 16, 2019
    Date of Event
    September 4, 2017
    Report Date
    December 19, 2018
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN APPLYING THE STOPCOCK/LUER LOCK OF THE INLET LINE OF THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) TO INFLOW CANNULA, THERE WAS AN AUDIBLE CRACKING SOUND AND AIR WAS BEING ENTRAINED CREATING AND AIRLOCK WHICH STOPPED THE RVAD FROM CIRCULATING. THE PATIENT QUICKLY BECAME BRADYCARDIC AND HYPOTENSIVE. WE WERE UNSUCCESSFUL IN REMOVING THE AIR FROM THE CIRCUIT, REQUIRING A NEW RVAD CIRCUIT WITH OXYGENATOR. DESPITE NOW BEING ABLE TO FLOW NEARLY 3L/MIN, PATIENT'S PULMONARY ARTERY (PA) PRESSURES EQUALED SYSTEMIC. ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), HER RIGHT VENTRICLE (RV) WAS SEVERELY DILATED AND SHE WAS CONVERTED TO VENOUS ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) AND RIGHT FEMORAL ARTERY WAS ACCESSED USING A 17FR CANNULA OVER THE WIRE. THE PULMONARY ARTERY (PA) AND RIGHT ATRIUM (RA) CANNULA WERE Y-D TOGETHER AS THE OUTFLOW CANNULA. NEXT, THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WAS ACCESSED WITH A MICROPUNCTURE KIT USING ULTRASOUND GUIDANCE, AND A 7FR CANNULA WAS INSERTED OVER THE WIRE AND CONNECTED TO THE INFLOW CANNULA FOR DISTAL PERFUSION. THE DOCTOR REMOVED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46652 SORIN CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF LIVANOVA USA, INC. 1717700066

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Death