BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRD PRODUCTS CORP.

    MDR report key: 5109713 · Received September 15, 2015

    Report

    Report Number
    5109713
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 10, 2015
    Manufacturer
    CAREFUSION CORP.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE E. D. IN SEVERE DISTRESS, DIC, S. O. B., AND FEVER. PT WAS A LEUKEMIA PT WHO HAD PLATELET REPLACEMENT THE DAY PRIOR. PT WAS PLACED ON A RESPIRATOR FOR THE BREATHING ISSUES. PT 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 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 AC OUTLET. THE BATTERY EVENTUALLY RAN DOWN, AND THE VENTILATOR CEASED OPERATION, LEADING TO THE PT BECOMING HYPOTENSIVE AND BRADYCARDIC RESULTING IN CARDIAC ARREST. MFR REF # 2021710-2015-01745.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610548 BIRD PRODUCTS CORP. T-BIRD AVS III CBK CAREFUSION CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR HYROCORTISONE