BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA-HP DIALYZER (CA-HP 210)

    MDR report key: 297980 · Received September 22, 2000

    Report

    Report Number
    1423500-2000-00922
    Event Type
    Malfunction
    Date Received
    September 22, 2000
    Date of Event
    August 31, 2000
    Report Date
    August 31, 2000
    Manufacturer
    NISSHO CORP.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS 1 FIBER LEAK OCCURRED AT THE ONSET OF TREATMENT ON REUSE NUMBER 6. NOTED BY VISIBLE BLOOD IN THE DIALYSATE COMPARTMENT AND CONFIRMED WITH HEMASTIX. NO BLOOD LEAK ALARM OCCURRED. ESTIMATED BLOOD LOSS WAS 150CC. TREATMENT WAS CONTINUED WITH NEW DIALYZER AND BLOODLINES WITHOUT INCIDENT. NO PT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA-HP DIALYZER (CA-HP 210) HOLLOW FIBER DIALYZER FJI NISSHO CORP. CA-HP 210 E99L02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN RENATRON.