BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 277344 · Received May 9, 2000

    Report

    Report Number
    2916596-2000-00019
    Event Type
    Injury
    Date Received
    May 9, 2000
    Date of Event
    April 7, 2000
    Report Date
    April 10, 2000
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PT ON BIVENTRICULAR ASSIST DEVICES (BIVADS) WAS READING IN BED WHEN THE FILL SIGNAL, DRIVER PRESSURE AND THE UNINTERRUPTIBLE POWER SUPPLY (UPS) ALARMS WERE ACTIVATED, AND THE PT EXHIBITED SIGNS OF LOSING CONSCIOUSNESS. THE VADS CONTINUED TO PUMP FOR A SHORT TIME BUT EVENTUALLY STOPPED. THE PT WAS PUMPED WITH EMERGENCY HAND BULBS, UNTIL PT WAS SWITCHED TO A BACK UP DRIVE CONSOLE. THE PT RECOVERED IMMEDIATELY WITHOUT FURTHER INCIDENT. THE VAD DRIVE CONSOLE WAS EVALUATED AND THE FAILURE VERIFIED AT THE SITE BY A THORACTEC SERVICE TECHNICIAN WHO NOTED A MALFUNCTION IN THE UPS SYSTEM. THE UPS SYSTEM WAS RETURNED TO THORACTEC FOR FURTHER INVESTIGATION, BUT THE FAILURE MODE COULD NOT BE REPRODUCED. THE UPS SYSTEM HAS BEEN SENT TO THE VENDOR FOR FURTHER INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention