BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1963692 · Received December 21, 2010

    Report

    Report Number
    2916596-2010-00352
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    December 1, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED INTERMITTENT ALARMS WERE CONFIRMED DURING ANALYSIS. THE LOG FILE WAS REVIEWED AND THE DATA RECORDED WAS CONSISTENT WITH THE REPORTED EVENT. DURING FUNCTIONAL TESTING, WHILE MOVING THE BLACK POWER LEAD AT THE CONNECTOR END, THE SYSTEM RESPONDED WITH A POWER CABLE DISCONNECT ALARM. THE WHITE AND BLACK POWER LEADS WERE INDEPENDENTLY DISCONNECTED AND WHILE THE SYSTEM WAS SUPPORTED SOLELY BY THE BLACK POWER LEAD, A LOW BATTERY ALARM OCCURRED. DURING FURTHER INVESTIGATION, IT WAS FOUND THAT THE BROWN CONDUCTOR (BATTERY GAUGE LINE) OF THE BLACK POWER LEAD WAS SEVERED. 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 ALARMS. EARLIER IN THE DAY, THE PT HAD CALLED THE VAD COORDINATOR AND STATED THAT HIS MODULE HAD A CONTINUOUS AUDIO ALARM THAT HE WAS UNABLE TO SILENCE. THE PT WAS ON BATTERIES AT THE TIME AND TOOK THE INTERNAL BATTERY OUT OF THE POWER MODULE TO SILENCE THE ALARM. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARMS WERE RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other