BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 261880 · Received February 7, 2000

    Report

    Report Number
    2916596-2000-00002
    Event Type
    Other
    Date Received
    February 7, 2000
    Date of Event
    January 7, 2000
    Report Date
    January 7, 2000
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WHO WAS BEING SUPPORTED WITH BIVENTRICULAR ASSIST DEVICES (LEFT VENTRICULAR ASSIST DEVICE AND RIGHT VENTRICULAR ASSIST DEVICE) USED A PILLOW TO PROP THE RIGHT VENTRICULAR ASSIST DEVICE INTO A POSITION THAT PREVENTED RECURRENT VENTRICULAR ASSIST DEVICE DRIVER ALARMS FOR INCOMPLETE VENTRICULAR ASSIST DEVICE FILLING. IN DOING SO, PT KINKED THE VENTRICULAR ASSIST DEVICE CANNULAE, THUS RESTRICTING VENTRICULAR ASSIST DEVICE FLOW, WHICH CAUSED THROMBUS TO FORM IN THE RIGHT VENTRICULAR ASSIST DEVICE. THE PT EXHIBITED SIGNS OF LOW BLOOD PRESSURE AND REQUIRED A REOPERATION TO REPLACE THE RIGHT VENTRICULAR ASSIST DEVICE. THE PT RECOVERED WELL FROM THE OPERATION AND VENTRICULAR ASSIST DEVICE FLOW RATES IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE (BLOOD PUMP) DSQ THORATEC LABORATORIES CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention