BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3093835 · Received April 30, 2013

    Report

    Report Number
    2916596-2013-00514
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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 A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PATIENT WAS IN THE OPERATING ROOM WHILE THE PUMP WAS RUNNING. THE DOCTOR REALIZED THAT THE PATIENT'S URINE OUTPUT WAS "COFFEE COLORED" SO HE ASKED FOR A PUMP EXCHANGE BEFORE THEY LEFT THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187678 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122334

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention