BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1852375 · Received September 29, 2010

    Report

    Report Number
    2916596-2010-00245
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REVIEW OF THE LOG FILE REVEALED VARIOUS ALARM CONDITIONS, INCLUDING "LOW SPEED HAZARD", "LOW FLOW HAZARD" AND "MOTOR STOPPED" ALARMS DUE TO THE "MOTOR STOP COMMAND RECEIVED" EVENTS, CONFIRMING THE REPORTED EVENT OF THE PUMP SPONTANEOUSLY STOPPING AT 6000 RPMS DURING IMPLANT. PER THE MANUFACTURER'S DESIGN, IF THE PUMP IS OPERATING AT THE IMPLANT SET SPEED OF 6000 RPM AND MINIMAL TO NO FLOW THROUGH THE PUMP, IT IS POSSIBLE THAT THE PUMP POWER CONSUMPTION MAY DROP BELOW 0.1A WHICH CAN CAUSE THE PUMP TO STOP SINCE THE CONTROLLER SENSES THAT THE PUMP IS NOT CONNECTED UNDER THESE CONDITIONS. PUMP POWER CONSUMPTION ABOVE 0.1A RESOLVES THIS PHENOMENON. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND EXERCISED FOR APPROXIMATELY EIGHT HOURS WHILE CONNECTED TO A TEST PUMP, MOCK CIRCULATORY LOOP, POWER BASE UNIT, AND SYSTEM MONITOR. THE SYSTEM CONTROLLER WAS FOUND TO FUNCTION AS INTENDED DURING ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT UPON INITIATION OF THE LVAD PUMP DURING IMPLANT, THE PUMP SPONTANEOUSLY STOPPED THREE TIMES AFTER 30-90 SECONDS OF NORMAL FUNCTIONING AT 6000RPM. THE SYSTEM CONTROLLER WAS THEN EXCHANGED AND PUMP FUNCTIONED NORMALLY FROM THAT POINT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention