BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 485562 · Received September 23, 2003

    Report

    Report Number
    2916596-2003-00102
    Event Type
    Injury
    Date Received
    September 23, 2003
    Date of Event
    September 8, 2003
    Report Date
    September 8, 2003
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, THE HOSPITAL CONTACTED THE MFR TO REPORT THAT A DUAL DRIVE CONSOLE (DDC) SUPPORTING A BI-VENTRICULAR ASSIST DEVICE (BI-VAD) PT IMPLANTED IN 2003, HAD MALFUNCTIONED. THE BOTTOM MODULE OF THE DDC HAD LOCKED-UP, WHICH RESULTED IN ONE OF THE BI-VADS STOPPING AND BOTH THE TOP AND BOTTOM MODULES OF THE DDC ALARMING. UPON HEARING THE ALARMING, THE HOSPITAL STAFF ENGAGED THE EMERGENCY SELECTOR VALVE, WHICH ALLOWED BOTH VAD'S TO RUN OFF OF ONE MODULE UNTIL THE PT WAS SWITCHED TO A BACK-UP DDC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE (DDC) DSQ THORATEC CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention