BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURECELL ECQ

    MDR report key: 656361 · Received December 6, 2005

    Report

    Report Number
    656361
    Event Type
    Malfunction
    Date Received
    December 6, 2005
    Date of Event
    December 1, 2005
    Report Date
    December 6, 2005
    Manufacturer
    PALL BIOMEDICAL PRODUCTS, CO.
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A UNIT OF RED BLOOD CELLS WERE HUNG FOR INFUSION ON A PEDIATRIC PATIENT IN THE PICU. A LEAK WAS NOTED FROM THE FILTER AND THE BLOOD TRANSFUSION WAS IMMEDIATELY STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURECELL ECQ HIGH EFFICIENCY RAPID FLOW LEUKOCYTE REDUCTION FILTER CAK PALL BIOMEDICAL PRODUCTS, CO. * 0550614

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR