BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE-II

    MDR report key: 3806883 · Received May 7, 2014

    Report

    Report Number
    MW5036032
    Event Type
    Death
    Date Received
    May 7, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 6, 2014
    Manufacturer
    THORATEC LAB
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT ASLEEP WHEN HM-II POCKET CONTROLLER ISSUES AN AUDIBLE ALARM AND "CHANGE CONTROLLER" TEXT. THE PT ATTEMPTED TO CHANGE TO A SPARE DEVICE BUT DID NOT COMPLETE THE PROCESS AND DIED. THIS PT AND HIS FAMILY WERE EXTENSIVELY RETRAINED ON THIS PROCESS SEVERAL DAYS EARLIER. THE POCKET CONTROLLER ISSUED A CONFUSING MESSAGE, THAT DID NOT REFLECT THE SITUATION. THE MESSAGE SHOULD HAVE BEEN "CALL YOUR HOSPITAL". THE LVAD WAS RUNNING WELL AND THERE WAS NO DANGER. THE DESIGN OF THE POCKET CONTROLLER HAS MADE DRIVELINE CONNECTION MUCH MORE DIFFICULT THAN THE PRIOR DESIGN. THE PC ALSO HAS A YELLOW WRENCH ICON NOT USED ON THE PRIOR DEVICE. PTS ARE IN-FACT TRAINED ON THE USE OF THESE NEW CONTROLLERS, INTENSIVELY. THE DEVICE IS MORE COMPLICATED, HARDER TO USE AND PRONE TO SPURIOUS ALARMS. ALL RENDER THE POCKET CONTROLLER A RISK COMPARED TO PRIOR DESIGN. YES, THE PC COMES WITH AN INTERNAL BATTERY DESIGNED TO RUN THE PUMP BRIEFLY, IF DISCONNECTED FROM MAIN POWER OR RECHARGABLE BATTERIES, BUT THE CONNECTION OF THE DRIVELINE IS MARKEDLY MORE DIFFICULT TO INSERT. ALIGNMENT IS NOW MORE DIFFICULT, THE FORCE REQUIRED IS NOW INCREASED AND THE MESSAGING DISPLAYED IS NOW CONFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276184 HEARTMATE-II HEARTMATE-II DSQ THORATEC LAB SYSTEM CONTROLLER

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death