BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRD

    MDR report key: 359922 · Received November 6, 2001

    Report

    Report Number
    359922
    Event Type
    Injury
    Date Received
    November 6, 2001
    Date of Event
    February 14, 2001
    Report Date
    May 23, 2001
    Manufacturer
    BIRD PRODUCTS CORP.
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING AGGRESSIVE HEMODYNAMIC STABILIZATION MEASURES INCLUDING CENTRAL VENOUS LINE, FLUID RESUSCITATION AND PRESSORS. IN 2001, PT EXPERIENCED CARDIOPULMONARY FAILURE AND WAS STARTED ON ESTRACORPOREAL MEMBRANE OXYGENATION CANNULATION. A POP-OFF VALVE WAS PLACED IN THE VENTILATING GAS TUBING PROXIMAL TO THE GAS PHASE OF THE ARTIFICIAL LUNG, TO PREVENT AIR EMBOLUS IF OCCLUSION OF THE OUTLET GAS PHASE OCCURS. THE CO2 CONTENT IN THE PT'S BLOOD OCCURRED BEFORE AND AFTER THE OXYGENATION. WHEN THE POP-OFF VALVE WAS REMOVED, THE PCO2 LEVEL ON THE PT AND ECMO CIRCUIT DECREASED. THE POP-OFF VALVE WAS MEASURED AND RECORDED TO POP OFF AT 30CM H20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49539 BIRD VALVE, RELIEF, 30 CMH2O MNJ BIRD PRODUCTS CORP. 04230 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention