BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2980804 · Received February 21, 2013

    Report

    Report Number
    2916596-2013-00194
    Event Type
    Death
    Date Received
    February 21, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 24, 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 DEVICE WAS RETURNED TO THE MFR, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED INTO THE HOSPITAL. THE PT'S LDH WAS 3000, PHGB 33, AND HIS URINE WAS TEA-COLORED. THE PT HAD BEEN OFF OF ANTICOAGULATION MEDICATION DUE TO GI BLEEDS, BUT WAS STARTED ON IT AGAIN ONCE HE WAS ADMITTED INTO THE HOSPITAL. THE PT'S INR WAS 2.0. TWO DAYS LATER THE PT'S HEMOGLOBIN DROPPED TO 7.3. HE WAS GIVEN 1 UNIT OF PACKED RED BLOOD CELLS AND HIS HEMOGLOBIN INCREASED TO 9.1. A FEW WEEKS LATER IT WAS REPORTED THAT THE PT WAS RUSHED OVER THE ICU FOR INCREASING OXYGENATION NEEDS AND HYPOTENSION. HE WAS ON A NRB ALL DAY (GASES AND MENTAL STATUS WERE OK). THE NEXT 24 HOURS HE HAD PUT OUT 100CC OF URINE. CREATININE WAS 3.98 IN THE MORNING, AND 4.63 IN THE EVENING. HE HAD A QUINTON PLACED AND CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD) WAS TO BE STARTED THAT NIGHT. THE PT WAS STARTED ON NEO DUE TO HYPOTENSION (MAP VIA NON-INVASIVE BLOOD PRESSURE (NIBP) CUFF WAS IN THE LOW 50S. ADD'L INFO WAS RECEIVED FROM THE VAD COORDINATOR THAT THE PT EXPIRED 6 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76881 HEARTMATE II LVAS DSQ: LEFT VENTIRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114713

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death