BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2180663 · Received May 5, 2011

    Report

    Report Number
    2916596-2011-00168
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    January 10, 2011
    Report Date
    April 11, 2011
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF UNK AUDIBLE ALARMS WAS CONFIRMED DURING ANALYSIS. POWER CABLE DISCONNECT BECAME ACTIVE WHEN THE BLACK CABLE WAS MANEUVERED. THE BLACK CABLE WAS STRIPPED AT THE CONNECTOR END, AND THE (BROWN) BATTERY GAUGE WIRE WAS CONFIRMED TO BE BROKEN. THE BROKEN CONDITION OF THE BATTERY GAUGE LINE RESULTED IN A FALSE OWNER CABLE DISCONNECT ALARM. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO 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. THE PERFUSIONIST REPORTED THAT THE PT RECEIVED INTERMITTENT ALARMS. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP 103696 92619

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other