BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3912869 · Received May 14, 2014

    Report

    Report Number
    2916596-2014-00763
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    October 29, 2013
    Report Date
    April 14, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED EVENT OF A NONFUNCTIONAL SYSTEM CONTROLLER WAS CONFIRMED DURING ANALYSIS. UPON RECEIVING THE SYSTEM CONTROLLER, BLOOD WAS NOTED INSIDE THE BULKHEAD CONNECTOR OF THE SYSTEM CONTROLLER. THE SYSTEM CONTROLLER WOULD NOT OPERATE A TEST PUMP WHEN IT WAS CONNECTED. THE INTERNAL MAKINGS OF THE SYSTEM CONTROLLER WERE EXAMINED AND A RESIDUE OF BLOOD FLUID WAS OBSERVED THROUGHOUT THE INSIDE COMPARTMENT. THERE WAS ALSO DAMAGE, BY WAY OF BURNT AREAS NOTED TO THE INTERNAL PRINTED CIRCUIT BOARD (PCB). THE SYSTEM CONTROLLER WAS EXPOSED TO FLUID WHICH SHORTED AND DAMAGED THE INTERNAL PCB. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THIS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE SYSTEM CONTROLLER WOULD NOT WORK. DURING THE MANUFACTURER'S INITIAL INVESTIGATION OF THE RETURNED SYSTEM CONTROLLER, IT WAS FOUND THAT THE DEVICE WOULD NOT OPERATE A TEST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288131 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 106762 129252

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention