BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVACOR

    MDR report key: 613079 · Received May 27, 2005

    Report

    Report Number
    613079
    Event Type
    Other
    Date Received
    May 27, 2005
    Date of Event
    May 8, 2005
    Report Date
    May 11, 2005
    Manufacturer
    WORLDHEART, INC.
    Product Code
    DSQ
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTED LAST YEAR. SEVERAL MONTHS LATER, THE PATIENT WAS TALKING ON THE PHONE IN THE HOSPITAL ROOM WHEN THE LVAD ALARMED. UPON ASSESSMENT, THE PATIENT WAS ASYMPTOMATIC. THE LVAD CONTINUED TO ALARM, AND THE NURSE REPLACED THE BATTERIES, AND CHECKED THE CABLES AND CONNECTIONS, TO NO AVAIL. A SECOND NURSE CAME IN TO ASSESS THE PATIENT AND THE EQUIPMENT. THE NURSE WAS UNABLE TO FIND ANYTHING WRONG, AND THE PATIENT WAS INSTRUCTED TO HANG UP THE PHONE AND LIE FLAT. THE CONTROLLER AND BATTERIES WERE CHANGED. THE LVAD CONTINUED TO ALARM. THE PHYSICIAN AND PERFUSIONIST WERE CALLED. THE LVAD STOPPED PUMPING AND THE PATIENT BECAME PULSELESS. A CODE WAS CALLED. THE PATIENT WAS BAGGED AND CHEST COMPRESSIONS WERE STARTED. THE PHYSICIAN CAME INTO THE ROOM AND ASSESSED THE PATIENT. THE PHYSICIAN FOUND THE CABLE TO THE CONTROLLER WAS NOT COMPLETELY CONNECTED. ONCE IT WAS RECONNECTED, THE LVAD STARTED PUMPING AND THE PATIENT RECOVERED. THE PATIENT WAS TRANSFERRED TO THE ICU OVERNIGHT. THE COMPANY'S CLINICAL CONSULTANT CAME TO INSPECT THE EQUIPMENT. THERE WERE NO DEFECTS IN THE CABLE; ALL THE PINS WERE IN PERFECT CONDITION. THE ALARM HISTORY INDICATED "LOW PUMP OUTPUT" AND "PREMATURE UNLATCH" BOTH OF WHICH ARE REPRODUCIBLE WHEN THE CABLE IS NOT SECURELY CONNECTED TO THE CONTROLLER. WHAT THE STAFF DID NOT KNOW WAS THAT IT CAN BE DISCERNED THE CABLE IS NOT ATTACHED BY LOOKING IN THE PORTAL ON THE SIDE OF THE CONTROLLER; IF ANY SHINY SILVER CAN BE SEEN, THE CABLE IS NOT SECURELY CONNECTED. THE HOSPITAL IS WONDERING IF THERE IS A WAY TO MAKE IT MORE OBVIOUS WHEN THE CABLE IS NOT COMPLETELY CONNECTED BY CHANGING THE SHINEY SILVER PART TO RED OR SOME OTHER MEANS. AN EDUCATIONAL MEMO WENT OUT TO STAFF ABOUT TROUBLESHOOTING WHEN ALARMS SOUNDS AND CHECKING THE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVACOR LEFT-VENTRICULAR ASSIST SYSTEM DSQ WORLDHEART, INC. * *
    2 NOVACOR LVAD INFLOW VALVED CONDUIT DSQ WORLD HEART, INC. * *
    3 NOVACOR LVAD OUTFLOW VALVED CONDUIT DSQ WORLD HEART, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR