BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3912868 · Received May 14, 2014

    Report

    Report Number
    2916596-2014-00767
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPERIENCED AN ALARM AND THEN DEVELOPED PAIN IN HER ABDOMEN. REVIEW OF THE HISTORY SHOWED MULTIPLE LOW SPEED OPERATION AND PUMP OFF EVENTS AND AN INCREASE IN POWER. WHILE THE PATIENT WAS IN THE ER NO ALARMS OCCURRED. THE LOG FILE WAS REVIEWED BY THE MANUFACTURER'S TECHNICAL SERVICE GROUP AND THE REPORTED LOW SPEED AND PUMP OFF EVENTS WERE NOTED WHILE THE PATIENT WAS ON BATTERY POWER AND CONNECTED TO THE POWER MODULE. THE PATIENT'S SYSTEM CONTROLLER AND POWER MODULE PATIENT CABLE WERE EXCHANGED. IT WAS REPORTED 7 DAYS LATER THAT THE PATIENT HAS HAD NO FURTHER ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288485 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 119675

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other