BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1883229 · Received October 20, 2010

    Report

    Report Number
    2916596-2010-00260
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    June 24, 2010
    Report Date
    September 30, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVAL AND THE REPORTED EVENT WAS CONFIRMED. THE SYSTEM CONTROLLER WAS CONNECTED TO A MOCK LOOP SET UP WITH A TEST PUMP AND THE SYSTEM WOULD NOT RUN. THE SYSTEM CONTROLLER WAS OPENED AND UPON VISUAL INSPECTION OF THE INTERNAL PRINTED CIRCUIT BOARD (PCB), IT WAS DISCOVERED THAT THE COMPONENT THAT MONITORS THE MOTOR CURRENT WAS NON-FUNCTIONAL. THE OUTPUT FROM THIS COMPONENT WHICH PROVIDES AN INDICATION TO THE MICROPROCESSOR THAT THE PUMP IS CONNECTED DID NOT HAVE A SIGNAL. FURTHER EVAL OF THE DEFECTIVE COMPONENT UNDER X-RAY DID NOT REVEAL ANY DISRUPTIONS ALONG THE CONTACT LINES TO EACH PIN. THE ROOT CAUSE FOR THIS COMPONENT TO BECOME NON-FUNCTIONAL COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT PUMP FUNCTION OR PERFORMANCE. 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 (LVAD). THE VAD COORDINATOR REPORTED THAT APPROXIMATELY ONE WEEK POST IMPLANT AND WHILE THE PT WAS STILL IN THE HOSPITAL, THE SYSTEM CONTROLLER WAS PRODUCING AUDIBLE ALARMS AND DISPLAYING A VOLTAGE LEVEL OF 0.7 VOLTS WHILE THE PT WAS CONNECTED TO THE POWER BASE UNIT (PBU) OR TO THE POWER MODULE (PM).

    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 21 YR Other