BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)

    MDR report key: 2166840 · Received July 13, 2011

    Report

    Report Number
    2916596-2011-00290
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. 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

    IT WAS REPORTED BY THE VAD COORDINATOR THAT ON (B)(6), 2011, THE PATIENT WAS SWITCHED FROM THE DUAL DRIVE CONSOLE (DDC) TO A PORTABLE TLC II DRIVER TO GO FOR A WALK. WHILE THE PATIENT WAS DISCONNECTED FROM THE DDC, THE NURSES PRESSED THE CLEAR BUTTON MULTIPLE TIMES TO SILENCE THE ALARMS. WHEN THE PATIENT WAS PLACED BACK ON THE DDC, SHE STARTED HAVING TROUBLE BREATHING AND DEVELOPED SYMPTOMS OF RESPIRATORY DISTRESS. THE PATIENT WAS REINTUBATED AND IT WAS NOTED THAT THE DDC LVAD SUPPORT WAS IN ASYNC MODE WHILE THE RVAD SUPPORT WAS IN VOLUME MODE, WHEN BOTH THE LVAD AND RVAD SHOULD HAVE BEEN ON VOLUME MODE. IT WAS UNCLEAR HOW LONG THE PATIENT WAS IN ASYNC MODE. THREE DAYS LATER, THE NURSE HEARD THE VAD ALARMING WITH SYNC ALARMS ON THE TOP MODULE (LVAD SUPPORT) SO THE CLEAR BUTTON WAS PUSHED ON THE CONSOLE. WHEN CHECKING THE PATIENT'S CANNULAS AND FLASH, IT WAS NOTICED THAT THE FLASH WAS DIMINISHED. THE DDC WAS CHECKED AND THE TOP MODULE (LVAD SUPPORT) WAS NOW IN ASYNC WHEN IT HAD BEEN IN VOLUME MODE. THE VOLUME BUTTON WAS THEN PUSHED TO RETURN THE MODULE BACK TO VOLUME MODE. THE EVENT COULD NOT BE DUPLICATED AGAIN. THE DDC WAS REPLACED WITH ANOTHER DDC AND NO FURTHER PROBLEMS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention