BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE VE SYSTEM CONTROLLER

    MDR report key: 1222829 · Received November 6, 2008

    Report

    Report Number
    2916596-2008-00152
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND DURING A CLINIC VISIT AT THE HOSPITAL, THE VAD COORDINATOR REPORTED THAT WHILE SWITCHING POWER SOURCES FROM THE POWER BASE UNIT (PBU) TO BATTERY SUPPORT, THE PT EXPERIENCED A RED BATTERY ALARM, CONTINUOUS AUDIBLE ALARM, RED HEART ALARM AND THE PUMP REPORTEDLY STOPPED. WHEN THE VAD COORDINATOR RE-CONNECTED THE PT BACK TO THE PBU, THERE WAS A RATE CONTROL FAULT ALARM AND THE PUMP SPEED WAS AT 50 BPM AND AFTER ABOUT TEN SECONDS, THE REPORTED ALARMS CLEARED. THE PT WAS SWITCHED TO A BACK-UP SYSTEM CONTROLLER DUE TO THE RATE CONTROL FAULT ALARM AND REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE VE SYSTEM CONTROLLER LVAD CONTROLLER DSQ THORATEC CORP. 1275 46701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention