BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA-HP DIALYZER (CA-HP 210)

    MDR report key: 236728 · Received August 18, 1999

    Report

    Report Number
    1423500-1999-00963
    Event Type
    Malfunction
    Date Received
    August 18, 1999
    Date of Event
    July 1, 1999
    Report Date
    July 21, 1999
    Manufacturer
    NISSHO 3-9-3
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL (HCP) REPORTS 3 BLOOD LEAKS NOTED INTO THE DIALYSATE COMPARTMENT DURING PT TREATMENTS. NEW DISPOSABLES USED TO CONTINUE TREATMENTS WITHOUT INCIDENT. ESTIMATED BLOOD LOSS OF 250CC REPORTED WITH EACH EVENT. ONE PT HAD TWO INCIDENTS. DIALYZERS REUSED 2,2 AND 10 TIMES PRIOR TO THESE REPORTS. HEALTH CARE PROFESSIONAL REPORTS NO PT INJURY OR NEED FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA-HP DIALYZER (CA-HP 210) HOLLOW FIBER DIALYZER FJI NISSHO 3-9-3 CA-HP 210 A99C03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN RENATRON