BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1812350 · Received August 19, 2010

    Report

    Report Number
    2916596-2010-00216
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    May 21, 2010
    Report Date
    July 29, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    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 MANUFACTURER FOR EVALUATION. THE REPORT OF LOW BATTERY ALARMS WHILE CONNECTED TO THE POWER MODULE WAS CONFIRMED AND REPRODUCED DURING ANALYSIS. THE SYSTEM CONTROLLER WAS CONNECTED TO A POWER MODULE, CABLE AND SYSTEM MONITOR IN THE MANUFACTURER'S LAB. THE LOG FILE WAS RETRIEVED WHICH REVEALED A LOW SPEED HAZARD, LOW BATTERY HAZARD, LOW FLOW HAZARD AND BACK-UP CPU ACTIVE ALARMS, ACTIVE. THE SYSTEM CONTROLLER WAS THEN CONNECTED TO A TEST PUMP AND THE SYSTEM BEGAN RUNNING AT 9200 RPMS WITH NO ALARMS ACTIVE. HOWEVER, WHILE MANEUVERING THE CABLES, AND WHILE MOVING THE BLACK POWER CABLE AT THE CONNECTOR END, THE SYSTEM REPORTED A POWER CABLE DISCONNECT ALARM PROCEEDED BY A RED BATTERY ALARM, AT WHICH TIME SUPPORT TO THE PUMP APPEARED TO BE INTERRUPTED AND INTERMITTENT. THE SYSTEM CONTROLLER WAS DISCONNECTED FROM THE PUMP AND THE OUTER INSULATION AT THE CONNECTOR END OF THE BLACK POWER CABLE WAS REMOVED. THE EXPOSED INNER CONDUCTORS REVEALED COMPROMISED CONDUCTORS AT THE CONNECTOR END. MOVEMENT OF THE BLACK POWER CABLE AT THE CONNECTOR END RESULTED IN LOW BATTERY AND CABLE DISCONNECT ALARMS AS WELL AS INTERRUPTION IN PUMP SUPPORT WHILE TETHERED TO THE POWER MODEL. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS EXPERIENCING ALARMS WHILE PLUGGED INTO THE POWER MODULE. THE VAD COORDINATOR SWITCHED OUT THE POWER MODULE AND POWER MODULE PATIENT CABLE, HOWEVER, THE PATIENT WAS STILL HAVING LOW BATTERY ALARMS WHILE ATTACHED TO THE POWER MODULE. THE SYSTEM CONTROLLER WAS SWAPPED OUT WITH ANOTHER SYSTEM CONTROLLER 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 82023

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR