BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSEM CONTROLLER

    MDR report key: 3843589 · Received March 25, 2014

    Report

    Report Number
    2916596-2014-00295
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO THE MANUFACTURER FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS HAVING CONTINUOUS LOW FLOW ALARMS IN THE OPERATING ROOM FOLLOWING A PUMP EXCHANGE (REFERENCE MFR # 0002916596-2014-00294). THE PT WAS "HEMODYNAMICALLY STABLE WITH A MAP OF 88." THE PUMP SPEED WAS SET AT 9400 RPM'S; GOOD LEFT VENTRICLE DECOMPRESSION; SEPTUM MIDLINE WITH HYPOKINETIC RIGHT VENTRICLE; AV REMAINED CLOSED WITH EACH BEAT. THE SYSTEM CONTROLLER WAS EXCHANGED, AS WELL AS, REDUCE MAP TO A GOAL OF 70-80. MEDICATION WAS INITIATED AND THE PT'S MAP WAS REDUCED TO 74. THE PT'S SYSTEM CONTROLLER THEN DISPLAYED A FLOW OF 4.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174131 HEARTMATE II SYSEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 135840

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR