BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3202043 · Received June 27, 2013

    Report

    Report Number
    2916596-2013-00796
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT WITH THE PUMP. THE DEVICE REMAINS IMPLANTED AND IN USE BY THE PATIENT. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED DURING IMPLANTATION OF THE PUMP, THAT THE PUMP AUTOMATICALLY TURNED OFF WHILE DE-AIRING. THE PUMP SPEED WAS CHANGED TO 7000 RPM AND THE PUMP CONTINUED TO STOP AUTOMATICALLY. THE SYSTEM CONTROLLER WAS EXCHANGED HOWEVER THERE WERE NO IMPROVEMENTS. ECHOCARDIOGRAM SHOWED NO AIR IN THE LEFT VENTRICLE. WHEN THE PUMP SPEED WAS INCREASED TO 8000 RPM, THE PUMP WAS ABLE TO START AND A LOT OF AIR WAS PRESENT IN THE LEFT VENTRICLE. THE PUMP OUTFLOW HAD TO BE DISCONNECTED IN ORDER TO GET RID OF ALL THE FROTHY BLOOD DUE TO AIR IN THE PUMP. SOME AIR GOT DOWN TO THE RIGHT CORONARY ARTERY AND CAUSED TRANSIENT ST ELEVATION. CENTRAL VENOUS PRESSURE (CVP) WAS OKAY INDICATING THE RIGHT VENTRICLE FUNCTION IS STILL ACCEPTABLE. THE HOSPITAL TEAM CONTINUED TO DE-AIR THE PUMP UNTIL NO MORE AIR COULD BE SEEN UNDER AN ECHOCARDIOGRAM. THE FINAL SPEED WAS SET AT 8800 RPM WITH LOW SPEED LIMIT AT 8400 RPM; FLOW WAS AROUND 3-4 WITH FREQUENT "---" DISPLAYED. THE PATIENT WOKE UP AND WAS EXTUBATED 10 HOURS POST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292177 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 125085

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention