BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    MDR report key: 2181347 · Received July 21, 2011

    Report

    Report Number
    2916596-2011-00300
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS STABLE ON VAD SUPPORT. THE DEVICE IS BEING ANALYZED ON SITE BY THE MANUFACTURER'S TECHNICAL SERVICE PERSONNEL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. THERE IS NO FURTHER INFO AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD COORDINATOR THAT THE TOP MODULE OF THE DUAL DRIVE CONSOLE (DDC) STOPPED PUMPING THE PT'S VAD PUMP. THE PT WAS HAND PUMPED AND WAS SWITCHED TO A BACKUP DDC. DURING THE EVENT, A PRESSURE ALARM WAS SEEN AND NO DRIVE LINE PRESSURE WAS FELT OUT OF THE BACK ON THE CONSOLE.

    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 63 YR Required Intervention