BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    MDR report key: 2030912 · Received March 21, 2011

    Report

    Report Number
    2916596-2011-00116
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS EXAMINED BY THE MFR'S FIELD SERVICE REP. UPON ARRIVAL, THE SERVICE TECH ISOLATED THE FAULT TO A PRESSURE LEAK AT THE CONSOLE'S PUMP FITTING. ADDITIONALLY A KINKED DRIVELINE WAS FOUND. THE KINKED DRIVELINE PREVENTED THE CONSOLE FROM PUMPING NORMALLY WHILE IN USE ON THE PT. THE SYSTEM AIR LEAK AND KINKED TUBING WERE REPAIRED AND THE UNIT WAS TESTED PER THE MFR'S SERVICE PROCEDURES AND IT PASSED ALL PERFORMANCE SPECS. THE UNIT WAS RETURNED TO SERVICE. THE PT IS FINE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMED ENGINEER THAT THE DUAL DRIVE CONSOLE (DDC) WAS HISSING AND THE TOP MODULE WAS NOT FUNCTIONING. THE FOLLOWING DAY, THE MFR'S TECHNICAL SERVICE TECH WAS DISPATCHED ON SITE TO EVALUATE THE UNIT. UPON ARRIVAL, THE SERVICE TECH WAS INFORMED THAT THE TOP MODULE FAILED WHILE ON A PT AND STOPPED PUMPING AND THAT THE DRIVELINE KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC) VENTRICULAR ASSIST DEVICE SYSTEM (DDC) DSQ THORATEC CORPORATION 10025-2600-005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention