BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA-HP 170

    MDR report key: 289530 · Received August 7, 2000

    Report

    Report Number
    1423500-2000-00858
    Event Type
    Malfunction
    Date Received
    August 7, 2000
    Date of Event
    June 30, 2000
    Report Date
    August 4, 2000
    Manufacturer
    NISSHO CORP
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTS ONE INCIDENT OF A BLOOD LEAK ON REUSE NUMER 12. THIS WAS NOTED AT THE ONSET OF TREATMENT BY VISIBLE BLOOD IN THE DIALYSATE COMPARTMENT, BLOOD LEAK ALARM AND CONFIRMED WITH HEMASTIX. TREATMENT WAS CONTINUED WITH A NEW DIALYZER/CIRCUIT WITHOUT INCIDENT. ESTIMATED BLOOD LOSS WAS 150CC. NO PT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA-HP 170 HOLLOW FIBER DIALYZER FJI NISSHO CORP CA-HP 170 D99K25

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN RENATRON II.