BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3902101 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00729
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. 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 PT WAS IMPLANTED A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT HAD SEVERAL "LOW SPEED OPERATION" AND "LOW FLOW" ALARMS WHEN CONNECTED TO THE POWER MODULE. THE LOG FILE SUBMITTED FOR ANALYSIS REVEALED 2 LOW SPEED HAZARD/LOW FLOW HAZARD/RED HEART ALARMS. ADDITIONAL INFORMATION PROVIDED BY THE VAD COORDINATOR INDICATED THAT VISUALLY THE EXTERNAL LEAD HAD A VERY SMALL CRIMP JUST BEYOND THE STRAIN RELIEF WHERE IT WAS EASY TO BEND. THE VAD COORDINATOR MANIPULATED IT WITHOUT ANY ALARMS WHILE THE PT WAS CONNECTED TO BATTERIES. A REVIEW OF X-RAYS DISPLAYED A POINT OF CONCERN NEAR THE BEND RELIEF AREA OF THE DRIVELINE. TECHNICAL SERVICES EVALUATED THE PT'S DRIVELINE AND FOUND A BROKEN YELLOW WIRE DURING TROUBLESHOOTING. AN EXTERNAL PERCUTANEOUS LEAD REPLACEMENT WAS SUBSEQUENTLY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271375 HEARTMATE II LVAS DSQ: LEFT VENTRICUALR ASSIST DEVICE DSQ THORATEC CORP 104911 105452

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention