BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    MDR report key: 2151488 · Received June 21, 2011

    Report

    Report Number
    2916596-2011-00255
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL'S BIOMED ENGINEER REPAIRED THE TUBE AND THE DEVICE WAS SERVICED BY THE MANUFACTURER ONSITE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH TWO PARACORPOREAL VADS (PVAD) FOR BIVENTRICULAR SUPPORT. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS EXPERIENCING RVAD EJECT ISSUES ON A PORTABLE DRIVER AND WAS SWITCHED OVER TO THE DUAL DRIVE CONSOLE (DDC). AFTER A FEW HOURS OF NORMAL OPERATION, THE DDC TOP MODULE SUDDENLY LOST ALL PRESSURE AND THE PATIENT HAD TO BE HAND PUMPED AND SWITCHED OVER TO A BACKUP DDC. THE HOSPITAL'S BIOMEDICAL ENGINEER ISOLATED THE LOSS OF PRESSURE TO A BROKEN PRESSURE TUBE IN THE COMPRESSOR TRAY AND REPAIRED THE TUBE. THE PATIENT REMAINS ONGOING.

    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 CORP. 10025-2600-005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention