BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3003938 · Received March 12, 2013

    Report

    Report Number
    2916596-2013-00265
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CONTINUES ON LVAD SUPPORT. 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 VAD COORDINATOR (VC) REPORTED THAT THE PATIENT HAD A TRACHEOSTOMY. THE FOLLOWING DAY, THE VC REVIEWED THE HISTORY SCREEN AND OBSERVED THAT THERE WERE LOW FLOW ALARMS, AND SPEED DROPPING DOWN TO WELL BELOW THE SET SPEED. THE LOG FILE WAS REVIEWED BY THORATEC TECH SERVICES WHICH INDICATED THAT THE DATA APPEARS NORMAL UNTIL 26 HOURS PRIOR TO THE LOG RETRIEVAL WHERE A MOTOR STOP COMMAND IS RECEIVED BY THE SYSTEM CONTROLLER CAUSING THE PUMP SPEED TO DROP DOWN TO 130RPMS. FOLLOWING THIS EVENT THE PUMP POWER APPEARS TO ELEVATE WITH 10 POWER ELEVATIONS ABOVE 10 WATTS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103740 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115178

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other