BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX RX05 BABY-RX

    MDR report key: 509034 · Received January 30, 2004

    Report

    Report Number
    509034
    Event Type
    Injury
    Date Received
    January 30, 2004
    Date of Event
    January 20, 2004
    Report Date
    January 30, 2004
    Manufacturer
    TERUMO
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AIR EMBOLUS VIA CARDIOPULMONARY BYPASS MACHINE WHILE PERFORMING AN ATRIAL SEPTAL DEFECT REPAIR. INVESTIGATION IN PROGRESS; PRELIMINARY INFO INDICATES AN ISSUE WITH THE POSITIVE PRESSURE RELIEF VALVE ON THE OXYGENATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX RX05 BABY-RX POSITIVE PRESSURE RELIEF VALVE ON OXYGENATOR ECX TERUMO 62432 DM06

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| S