BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1163594 · Received September 17, 2008

    Report

    Report Number
    2916596-2008-00132
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVALUATION 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 CHIEF PERFUSIONIST REPORTED THAT A LEFT VENTRICULAR ASSIST DEVICE (LVAD) PT WITH A HISTORY OF METHICILLIN-RESISTANT STAPHYLOCOCCUS ARES (MSRA) INFECTION IN THE DRIVELINE WAS ADMITTED TO THE HOSP FOR SEPSIS INFECTION THAT PROGRESSED INTO MULTIPLE ORGAN FAILURE (MOF). THE PT REQUIRED INTUBATION AND HOSP PERSONNEL HAD DIFFICULTY CONTROLLING THE INTERNATIONAL NORMALIZED RATIO (INR). THE DEVICE STARTED TO PRESENT INCREASED FLOW RATES AND INCREASED POWER CONSUMPTION WITH DECREASED PULSATILITY INDEX (PI) VALUES. WAVEFORMS AND LOG FILE DATA SUBMITTED TO THE MFR FOR ANALYSIS REVEALED HIGHER THAN NORMAL PUMP CURRENT AND HIGH FLOWS. AS THE PT'S CONDITION CONTINUED TO DECLINE, THE DEVICE FUNCTION PRESENTED WITH WHAT APPEARED TO BE A THROMBUS WITHIN THE DEVICE AND THE HOSPITAL MADE A DECISION TO TURN OFF THE PUMP DUE TO LOW FLOW ALARMS. ADDITIONAL INFO SUBMITTED TO THE MFR INDICATED THAT THE PT EXPIRED DUE TO MULTIPLE ORGAN FAILURE (MOF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 59035

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| L