BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 531861 · Received March 9, 2004

    Report

    Report Number
    2916596-2004-00036
    Event Type
    Other
    Date Received
    March 9, 2004
    Date of Event
    February 8, 2004
    Report Date
    February 8, 2004
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, THE HOSP REPORTED THAT THE TOP MODULE OF THE BACK-UP DUAL DRIVE CONSOLE WAS HAVING DIFFICULTY RETAINING PRESSURE. THE STAFF WERE CHECKING THEIR BACK-UP EQUIPMENT AS THEIR COORDINATORS WERE GOING TO BE OUT AND THEY WANTED TO MAKE SURE EVERYTHING WAS OPERATIONAL AS NO OTHER BACK-UP EQUIPMENT IS AVAILABLE FOR USE. SINCE, THIS DRIVER IS THE BACK-UP EQUIPMENT FOR A BI-VAD PT BOTH MODULES WILL BE NEEDED IN THE EVENT THE PRIMARY EQUIPMENT WERE TO MALFUNCTION THE PT WOULD HAVE TO BE SUPPORTED IN THE EMERGENCY MODE ON THE BOTTOM MODULE OF THIS DRIVER. THIS MODE IS INTENDER FOR TEMPORARY RESOLUTION OF AN EVENT WITH EITHER MODULE UNTIL AN APPROPRIATE BACK-UP IS PLACED. IN THE EVENT BOTH MODULES FAIL THE PT WOULD HAVE TO BE HAND-PUMPED UNTIL A REPLACEMENT COULD BE LOCATED. NURSES HAVE BEEN INSTRUCTED TO USE THE BACK UP IN EMERGENCY MODE IF IT BECOMES NECESSARY. SVC CALL HAS BEEN PLACED, AND WILL BE EXECUTED BY THE NEXT DAY. PT IS IN ICU, AND STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other