BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2012225 · Received February 2, 2011

    Report

    Report Number
    2916596-2011-00049
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 4, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED POWER CABLE DISCONNECT ALARMS WERE CONFIRMED DURING ANALYSIS. DURING THE EVAL OF THE SYSTEM CONTROLLER, THE BLACK POWER LEAD WAS FOUND TO HAVE A COMPROMISED BROWN CONDUCTOR (BATTERY FUEL GAUGE LINE) AT THE CONNECTOR END. THE DAMAGE TO THE CONDUCTOR DID NOT AFFECT THE FUNCTION OF THE PUMP DURING ANALYSIS; HOWEVER, MOVEMENT OF THE POWER LEAD AT THE CONNECTOR END RESULTED IN THE REPORTED POWER CABLE DISCONNECT ALARMS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'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 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 EXPERIENCED INTERMITTENT POWER CABLE DISCONNECT ALARMS. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ISSUE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other