BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL PURECELL REO HIGH EFFICING RAPID FLOW

    MDR report key: 603550 · Received May 16, 2005

    Report

    Report Number
    603550
    Event Type
    Injury
    Date Received
    May 16, 2005
    Date of Event
    January 12, 2005
    Report Date
    May 11, 2005
    Manufacturer
    PALL MEDICAL
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PALL FILTERS (X3) FOR BLOOD TRANSFUSIONS FOUND TO LEAK. HAVE 10 OTHER REPORTS FROM 10/2004 - 04/2005 OF THESE FILTERS LEAKING AROUND SQUARE AIR VENT. HOSPITAL HAS BEEN WORKING WITH MANUFACTURER, BUT DEVICE HAS NOT IMPROVED. MANUFACTURER INDICATES PROBLEM WITH DEVICE FROM OTHER HOSPITALS, BUT HAS NOT REPORTED THIS TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL PURECELL REO HIGH EFFICING RAPID FLOW BLOOD TRANSFUSION FILTER CAK PALL MEDICAL RCQT 0429075

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention