BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2092637 · Received May 10, 2011

    Report

    Report Number
    2916596-2011-00190
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPERIENCED RED HEART ALARMS WHILE AT HOME WITH AN UNGROUNDED PT CABLE. THE PT WENT TO THE HOSPITAL AND THE SYSTEM CONTROLLER HISTORY (LOG FILE) WAS REVIEWED AND REVEALED "PUMP OFF, LOW FLOW AND ZERO FLOW" EVENTS. THESE EVENTS OCCURRED MULTIPLE TIMES. THE PT'S SYSTEM CONTROLLER WAS EXCHANGED WITH HIS BACKUP CONTROLLER WITHOUT RESOLUTION. THE PT PROCEEDED TO HAVE ADDITIONAL ALARMS OF PUMP OFF, LOW FLOW, NO FLOW AND ELEVATED WATTS DURING INTERMITTENT PUMP RESTART. AS A RESULT, THE FOLLOWING DAY THE PT'S LVAD WAS EXCHANGED WITH A NEW LVAD. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 87758

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention