BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER HEALTHCARE CORP

    MDR report key: 205052 · Received January 6, 1999

    Report

    Report Number
    MW1015359
    Event Type
    Malfunction
    Date Received
    January 6, 1999
    Date of Event
    January 4, 1999
    Report Date
    January 5, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE TUBING LEAKS AT THE FILTER ON THE DISTAL SIDE FROM THE SPIKE. THE TUBING ATTACHED TO THE FILTER IS FINE. THE LEAKAGE IS NOT DUE TO CONDENSATION. THE LEAKAGE IS SOMEWHERE IN THE BODY OF THE FILTER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER HEALTHCARE CORP IV SOLUTION SET 100" WITH .22 MICRON FILTER FPA BAXTER HEALTHCARE CORP. H1602C5487S13 Z213231R

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other