BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA-HP DIALYZER (CA-HP 210)

    MDR report key: 395935 · Received May 14, 2002

    Report

    Report Number
    1423500-2002-00624
    Event Type
    Malfunction
    Date Received
    May 14, 2002
    Date of Event
    April 16, 2002
    Report Date
    April 18, 2002
    Manufacturer
    NIPRO CORPORATION
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS MULTIPLE INCIDENTS OF FIBER LEAKS SINCE 04/2002. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA-HP DIALYZER (CA-HP 210) HOLLOW FIBER DIALYZER FJI NIPRO CORPORATION CA-HP 210 E01K19

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN