BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2211937 · Received August 10, 2011

    Report

    Report Number
    2916596-2011-00347
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    March 15, 2011
    Report Date
    July 14, 2011
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. WHEN THE SYSTEM CONTROLLER WAS CONNECTED TO A HEARTMATE II MOCK CIRCULATORY LOOP, THE SYSTEM REPORTED A "POWER CABLE DISCONNECT" ALARM. IN ADDITION, WHEN THE BLACK POWER LEAD WAS MANIPULATED DURING TESTING, A "LOW BATTERY" ALARM BECAME ACTIVE WHICH PROGRESSED TO A "LOW BATTERY HAZARD" ALARM (INDICATING LOW VOLTAGE TO THE SYSTEM) AND THE TEST PUMP STOPPED. FURTHER EVALUATION OF THE BLACK POWER LEAD REVEALED A COMPROMISED BROWN WIRE AT THE CONNECTOR END. THE BROKEN BROWN WIRE WOULD HAVE RESULTED IN A LOW VOLTAGE CONDITION TO THE SYSTEM CONTROLLER RESULTING IN THE REPORTED 'REPLACE SYSTEM CONTROLLER" ADVISORY ALARM. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATION THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. 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. ALTHOUGH, THE MANUFACTURER DISCOVERED THAT THIS SYSTEM CONTROLLER HAD BEEN PREVIOUSLY USED ON ANOTHER PT PRIOR TO THE REPORTED EVENT, IT IS UNK WHEN THE DAMAGE TO THIS UNIT MAY HAVE OCCURRED OR HOW MANY TIMES IT WAS USED. THE CUSTOMER HAS BEEN REMINDED THAT THE HEARTMATE II SYSTEM CONTROLLER IS LABELED AS A "SINGLE USE" DEVICE AND SHOULD NOT BE USED ON MORE THAN ONE PT. NO FURTHER INFORMATION 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 (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WENT TO THE LOCAL EMERGENCY DEPARTMENT DUE TO EXPERIENCING "REPLACE SYSTEM CONTROLLER" ALARMS ON THE SYSTEM CONTROLLER. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED PER THE MANUFACTURER'S INSTRUCTIONS FOR USE AND THE PT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP 103696 85360

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other