BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2121962 · Received May 24, 2011

    Report

    Report Number
    2916596-2011-00211
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR, 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 LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT WHILE THE PT WAS TRYING TO TIE A SURGICAL MASK ON HIS HEAD SO SHE COULD CHECK HIS DRIVELINE, THE PT'S SPEED SUDDENLY DROPPED DOWN TO 5000 RPMS, THEN TO 2100 RPMS, AND THEN "PUMP STOP" WITH "NO FLOW" WAS DISPLAYED ON THE MONITOR, WITH NO AUDIBLE ALARM. THIS OCCURRED WITHIN APPROX 30-60 SECONDS. WHEN THE PT'S MASK WAS TIED AND HIS ARMS WERE DOWN, THE ISSUE RESOLVED. THE PT WAS NOT SYMPTOMATIC DURING THE EVENT. AN ECHO WAS PERFORMED AND "NOTHING ABNORMAL" WAS FOUND. THE PT'S SYSTEM CONTROLLER WAS EXCHANGED AND THE ISSUE WAS RESOLVED. THE VAD COORDINATOR HAD THE PT REPEAT ALL OF HIS STEPS (TYING THE MASK ON) AND THERE WAS NO CHANGE IN THE PUMP SPEED. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other