BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1980383 · Received January 29, 2011

    Report

    Report Number
    1980383
    Event Type
    Malfunction
    Date Received
    January 29, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 29, 2011
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEARTMATE II MONITOR SHOWING PUMP STOP ALARM WITH CONTINUOUS AUDIBLE ALARM. THE PATIENT HAS HAD HIS DEVICE FOR ABOUT EIGHT MONTHS AND HAS NEVER EXPERIENCED AN ALARM CONDITION. THE PATIENT WAS ADMITTED FOR HIGH BLOOD SUGAR AND WAS SITTING ON THE EDGE OF HIS BED WHEN THE PUMP STOP ALARM OCCURRED. DURING THE ALARM CONDITION, THE MONITOR DISPLAYED NO PUMP SPEED AND 0 WATTS OF POWER. THE DEVICE WAS OPERATING FROM A POWER MODULE AT THE TIME OF THE ALARM. THE DRIVE LINE LOOKED TO BE IN GOOD CONDITION AND AFTER SWITCHING THE PATIENT'S CONTROLLER, THE CLINICIAN MANIPULATED THE DRIVE LINE TO SEE IF THE ALARM COULD BE RECREATED. CLINICIAN COULD NOT GET ANY ALARM AND THE PUMP POWER REMAINED AT AROUND 5 WATTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR ASSIST BYPASS DSQ THORATEC 103694 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR