BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3111822 · Received May 7, 2013

    Report

    Report Number
    2916596-2013-00530
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 9, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HOME HEALTH AIDE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVALUATION. DURING THE ANALYSIS, WHEN THE SYSTEM CONTROLLER WAS CONNECTED TO THE TEST PUMP THE SYSTEM CONTROLLER DID NOT AUTOMATICALLY START (SET SPEED WAS SET AT 8800 RPM). THE DEVICE WAS FORCED INTO BACKUP MODE AND THE SYSTEM OPERATED AT 8800 RPM. FURTHER EVALUATION OF THE SYSTEM CONTROLLER REVEALED A DAMAGE COMPONENT ON THE MAIN PRINTED CIRCUIT BOARD (PCB) THAT RESULTED IN THE DEVICE BEING UNABLE TO OPERATE IN THE PRIMARY MODE. THE EVALUATION COULD NOT DETERMINE THE ROOT CAUSE OF THE COMPONENT FAILURE. A REVIEW OF THE DEVICE HISTORY REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION 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 WHILE THE PT WAS GETTING INTO HER CAR, THE PT'S SYSTEM CONTROLLER ALARMED WITH WHAT SHE BELIEVED WAS THE SELF-TEST. THE ALARM DID NOT STOP AFTER 5 TO 7 SECONDS. WHEN THE PT WAS EXCHANGING THE BATTERIES. SHE REMOVED THE FIRST BATTERY, THE TONES STOPPED, BUT THE RED HEART ALARM REMAINED. WHEN SHE REPLACED THE BATTERY, ALL LIGHTS/TONES CAME BACK ON. THE SAME HAPPENED WITH THE SECOND BATTERY. THE PT THE EXCHANGE HER SYSTEM CONTROLLER. THE PT WENT TO THE CLINIC, AND THE VAD COORDINATOR SWITCHED THE PT BACK TO THE PT'S PRIMARY SYSTEM CONTROLLER AND THE BACKUP MODE ALARM WAS ACTIVATED. THE PT WAS SWITCHED BACK TO HER BACKUP SYSTEM CONTROLLER AND WAS GIVEN A NEW SYSTEM CONTROLLER TO USE AS HER BACKUP. THE PT REMAINS ONGOING AND NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199982 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other