BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2960803 · Received February 11, 2013

    Report

    Report Number
    2916596-2013-00174
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY A VAD COORDINATOR THAT THE PATIENT HAD NOT LEFT THE HOSPITAL SINCE THE PUMP WAS IMPLANTED. THE PATIENT BEGAN RUNNING A FEVER AND HAD INCREASING WHITE BLOOD CELLS (WBC'S). A CT SCAN WAS PERFORMED AND IT WAS NOTED THAT THERE WAS AN AREA AROUND THE PUMP CAUSING CONCERN OF A PUMP POCKET INFECTION. THE PATIENT HAD BEEN DOING WELL WITH RECOVERY, AND ACCORDING TO THE PATIENT, HE FELT WELL. THE PHYSICIAN MADE A DECISION TO TAKE THE PATIENT BACK TO THE OPERATING ROOM TO CLEAN OUT THE PUMP POCKET TO ENSURE THE INFECTION MAY NOT SPREAD TO THE DRIVELINE OR BECOME WORSE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO POWER IRRIGATE THE PUMP POCKET. A DRAINAGE TUBE WAS PLACED TO ASSIST IN THE HEALING AND TO TAKE ANY CULTURES AS NEEDED. NO ISSUES WERE NOTED IN THE OPERATING ROOM AND THE PATIENT WAS TAKEN TO THE ICU. THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59746 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 121673

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention