BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREFUSION

    MDR report key: 5101599 · Received September 24, 2015

    Report

    Report Number
    2021710-2015-01745
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 15, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K950484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION WILL EVALUATE THE PRODUCT IF IT IS RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH# (B)(4): PATIENT PRESENTED TO THE E.D. IN SEVERE DISTRESS, DIG, S.O.B. AND FEVER. PATIENT WAS A LEUKEMIA PATIENT WHO HAD PLATELET REPLACEMENT THE DAY PRIOR. PATIENT WAS PLACED ON A RESPIRATOR FOR THE BREATHING ISSUES. PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC AND EVENTUALLY EXPIRED AFTER VENTILATOR BECAME NON- FUNCTIONAL DUE TO LOW/NO BATTERY POWER. THE ISSUE APPEARS TO BE DUE TO THE PLUG OF THE DEVICE AND NOT THE DEVICE ITSELF. AN AFTER-MARKET PLUG HAD AN INTERNAL CONNECTION THAT BECAME LOOSE WHICH DID NOT ALLOW THE DEVICE TO DRAW POWER FROM THE OUTLET. THE DEVICE APPEARS TO HAVE DRAWN POWER INTERMITTENTLY WHEN INITIALLY PLUGGED IN, BUT EVENTUALLY THE VENTILATOR SWITCHED TO BATTERY POWER, EVEN THOUGH THE DEVICE REMAINED PLUGGED IN TO A WORKING A/C OUTLET. THE BATTERY EVENTUALLY RAN DOWN, AND THE VENTILATOR CEASED OPERATION, LEADING TO THE PATIENT BECOMING HYPOTENSIVE AND BRADYCARDIC RESULTING IN CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630689 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION T-BIRD

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death