BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 289450 · Received August 7, 2000

    Report

    Report Number
    2916596-2000-00022
    Event Type
    Malfunction
    Date Received
    August 7, 2000
    Date of Event
    July 8, 2000
    Report Date
    August 7, 2000
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TOP MODULE OF THE DUAL DRIVE CONSOLE (DDC) STOPPED FUNCTIONING WHILE CONNECTED TO A BIVENTRICULAR ASSIST DEVICE (BIVAD) PT. THE PT WAS SWITCHED TO A BACK UP DRIVER WITHOUT INCIDENT. THE DUAL DRIVE CONSOLE WAS SHIPPED TO THORATEC AND THE FAILURE VERIFIED. INITIAL INVESTIGATION SHOWED THAT THE TOP MODULE BATTERY HOLDING RODS HAD COME LOOSE. IN ADDITION, THE HOLDING BRACKET FOR THE CIRCUIT BOARDS (COMPUTER AND ANALOG) WAS MISSING, WHICH ALLOWS THE CIRCUIT BOARDS TO COME LOOSE, PREVENTING THEM FROM BEING PROPERLY SEATED IN THE MOTHER BOARD. THORATEC IS IN THE PROCESS OF FURTHER INVESTIGATING THIS FAILURE. ANY NECESSARY CORRECTIVE ACTION WILL BE DETERMINED UPON COMPLETION OF THE FAILURE INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention