BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3896042 · Received May 15, 2014

    Report

    Report Number
    2916596-2014-00784
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HISTORY FROM THE RETURNED SYSTEM CONTROLLER WAS REVIEWED AND CONFIRMED THE REPORTED PUMP STOPPAGES AND LOW FLOW HAZARD ALARMS. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND THE TEST PUMP WAS NOT ABLE TO MAINTAIN THE PUMP SET SPEED AND THE PUMP STOPPED. MEASUREMENTS OF THE INTERNAL PRINTED CIRCUIT BOARD COMPONENTS ASSOCIATED WITH THE MOTOR DRIVE CIRCUITRY REVEALED A HIGHER RESISTANCE WHICH AFFECTED PUMP FUNCTION. THE MANUFACTURER HAS IMPLEMENTED A CHANGE FOR THIS TYPE OF OBSERVED PRINTED CIRCUIT BOARD ISSUE AND THIS SYSTEM CONTROLLER WAS MANUFACTURED PRIOR TO THE CHANGE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT WITH THE PUMP. THE SUSPECT SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER, 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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). ON THE DAY OF IMPLANT AND APPROXIMATELY 45 MINUTES AFTER THE PATIENT WAS TRANSFERRED TOT HE ICU, A RED HEART ALARM APPEARED AND THE SYSTEM MONITOR DISPLAYED "LOW FLOW AND PUMP OFF." THE HOSPITAL TEAM MADE SEVERAL ATTEMPTS TO RESTART THE PUMP WITH THE SYSTEM MONITOR; HOWEVER, THE PUMP WOULD START AND THEN IMMEDIATELY STOP AGAIN. DURING THE PUMP STOPPAGES THE AORTIC PRESSURE CURVE INCREASED AND THE MEAN BLOOD PRESSURE REMAINED STABLE. THE SYSTEM CONTROLLER WAS REPLACE WITH A BACKUP CONTROLLER AND THE PUMP RESTARTED. NO EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290369 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 106017 136683

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention