BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3072285 · Received April 19, 2013

    Report

    Report Number
    2916596-2013-00473
    Event Type
    Death
    Date Received
    April 19, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 23, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD BEEN HOSPITALIZED FOR APPROXIMATELY ONE WEEK WITH RESPIRATORY ISSUES. THE PATIENT WAS INTUBATED AND ADMINISTERED MEDICATION, INCLUDING AN ANTICOAGULANT. THE PATIENT EXPERIENCED LOW FLOW ALARMS FOR OVER 24 HOURS. THE NURSE NOTED THAT WHEN THE SPEED HAS BEEN INCREASED THE PATIENT HAS HEMOLYSED. THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) WAS 62, CENTRAL VENOUS PRESSURE (CVP) WAS 12, AND HIS INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.9. THE MANUFACTURER DISCUSSED WITH THE VAD COORDINATOR FACTORS THAT AFFECT LOW FLOW-LOW VOLUME, HIGH BLOOD PRESSURE, ETC. THE VAD COORDINATOR WAS GOING TO DISCUSS WITH PHYSICIAN GIVING THE PATIENT MORE VOLUME, INCREASING THE INR RANGE, CONTINUING TO KEEP THE MAP WITHIN THE MANUFACTURER'S "INSTRUCTIONS FOR USE" AND OBTAIN AN ECHO TO EVALUATE THE RIGHT AND LEFT SIDE OF THE HEART. ADDITIONAL INFORMATION WAS PROVIDED BY THE VAD COORDINATOR STATING THAT SUPPORT WAS WITHDRAWN FROM THE PATIENT A FEW DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170350 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118931

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death