BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2052124 · Received March 1, 2011

    Report

    Report Number
    2916596-2011-00085
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    September 8, 2010
    Report Date
    February 1, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    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 MFR FOR EVAL. THE SYSTEM CONTROLLER WAS CONNECTED TO THE EQUIPMENT IN THE MFR'S LAB. THE SYSTEM CONTROLLER ALARMS WHICH WERE REPORTED, COULD NOT BE INDUCED DURING THE ANALYSIS. HOWEVER, WHEN THE OUTER INSULATION OF THE BLACK POWER CABLE WAS REMOVED AT THE CONNECTOR END, DAMAGED INNER CONDUCTORS WERE REVEALED. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS EXPERIENCING MULTIPLE RANDOM AUDIO AND VISUAL ALARMING; "YELLOW BATTERY" AND "POWER CABLE DISCONNECTED". THE ALARMS WERE RECREATED BY MANEUVERING THE SYS CONTROLLER POWER LEADS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other