BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE MONITOR LINE

    MDR report key: 1003452 · Received February 23, 2008

    Report

    Report Number
    MW5005679
    Event Type
    Injury
    Date Received
    February 23, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 23, 2008
    Manufacturer
    SORIN CO
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ECMO SPECIALIST NOTED BUBBLES IN THE OXYGENATOR AND AT THE TOP OF THE BUBBLE TRAP AND BLOOD LEAKED FROM LAB LINE PIGTAIL-MONITOR LINE. ATTEMPT TO REMOVE AIR WAS UNSUCCESSFUL. ECMO SPECIALIST NOTED BLOOD LEAK FROM THE LAB LINE PIGTAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE MONITOR LINE COBE PEDIATRIC PERFUSION PACK DWF SORIN CO NA 0617000119

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening