BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    MDR report key: 1082973 · Received July 28, 2008

    Report

    Report Number
    2916596-2008-00100
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS STABLE ON BACK UP SUPPORT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'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 PERFUSIONIST THAT DURING AN ASSESSMENT THE RN WAS DOCUMENTING NUMBERS WHEN THE TOP MODULE SCREEN FROZE, UNABLE TO TOGGLE BETWEEN RATE, PRESSURE, VACUUM, ETC. LVAD CONTINUED PUMPING THEN THE RATE BEGAN TO DECREASE. TOP MODULE EVENTUALLY WENT BLANK. THE PT WAS SWITCHED TO THE BOTTOM MODULE WHICH DID NOT WORK. THEN THE HAND PUMPING BEGAN. PT HAD A FILL SIGNAL ON THE BOTTOM MODULE DURING THE HAND PUMPING. PERFUSIONIST CONFIRMED THE CABLES OF THE BOTTOM MODULE WERE PROPERLY CONNECTED. ADJUSTMENTS MADE TO THE VACUUM, DRIVE PRESSURE, AND RATE. NO FILL OR EMPTY DESPITE ADJUSTING DRIVE PRESSURE, EJECT DURATION, RATE, AND VACUUM. HAND PUMPING RESUMED. FILL SIGNAL PRESENT DURING THE HAND PUMPING AND PT STABLE. PT WAS SUCCESSFULLY SWITCHED TO A BACKUP DDC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC) VENTRICULAR DEVICE SYSTEM (DDC) DSQ THORATEC CORP. 10025-2600-005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention