BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3853691 · Received April 16, 2014

    Report

    Report Number
    2916596-2014-00525
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THE REPORT THAT WHEN ATTEMPTING TO CONNECT THE SYSTEM CONTROLLER TO A POWER SOURCE, TO CHARGE THE DEVICE, IT KEPT ALARMING WITH A RED HEART ALARM AND A CONNECT POWER SOURCE. THE LOG FILE CAPTURED EVENTS OCCURRING ON TWO DAYS INCLUDING THE REPORTED EVENT DATE OF (B)(6) 2014 REVEALING THAT THE SYSTEM CONTROLLER POWERED ON IN THE RUN MODE INSTEAD OF THE CHARGE MODE. THE SYSTEM CONTROLLER WAS POWERED DOWN MULTIPLE TIMES, ACCORDING TO THE LOG FILE, AND EACH TIME IT WAS RECONNECTED TO POWER THE SYSTEM CONTROLLER ENTERED RUN MODE, RESULTING IN THE REPORTED ALARMS. HOWEVER, THE SYSTEM CONTROLLER SHOULD TRANSITION TO CHARGE MODE WHEN CONNECTED TO POWER. DURING EVALUATION OF THE SYSTEM CONTROLLER, THE DRIVELINE WAS CONNECTED TO THE SYSTEM CONTROLLER AND OPERATED THE PUMP WITHOUT ISSUE, THE SPEED RAMPED UP AND REMAINED ABOVE THE LOW SPEED LIMIT. THE SYSTEM CONTROLLER WAS THEN DISCONNECTED AND RE-CONNECTED TO POWER MULTIPLE TIMES, AND EACH TIME THE SYSTEM CONTROLLER TRANSITIONED BETWEEN SLEEP MODE AND CHARGE MODE WITHOUT ISSUE. A SPECIFIC ROOT CAUSE FOR THE SYSTEM CONTROLLER POWERING ON IN THE RUN MODE COULD NOT BE IDENTIFIED AS THE RETURNED SYSTEM CONTROLLER FUNCTIONED AS INTENDED DURING ANALYSIS AND THE EVENT WAS NOT BE REPRODUCED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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. THE VAD COORDINATOR ATTEMPTED TO CHARGE THE BACK UP POCKET CONTROLLER, SINCE IT HAD NOT BEEN CHARGED SINCE JUNE 2013. WHEN THE VAD COORDINATOR ATTEMPTED TO CONNECT A POWER SOURCE TO CHARGE, IT KEPT ALARMING RED HEART AND "CONNECT POWER SOURCE". IT CONTINUES TO DO THIS EVENT AFTER SEVERAL ATTEMPTS TO DISCONNECT POWER AND PLACING IT IN SLEEP MODE THE INTERNAL BATTERY WAS REMOVED AND THE PROCESS STARTED OVER WITH THE SAME RED HEART ALARM WITH INSTRUCTION TO "CONNECT POWER SOURCE". THE POCKET CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233919 HEARTMATE II SYSTEM CONTROLLER DSQ:LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 128088

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention