BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL CA-210 DIALYZER

    MDR report key: 166910 · Received May 7, 1998

    Report

    Report Number
    1423500-1998-01322
    Event Type
    Malfunction
    Date Received
    May 7, 1998
    Date of Event
    April 21, 1998
    Report Date
    April 21, 1998
    Manufacturer
    NISSHO .
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED ONE USED SAMPLE FOR EVALUATION. THE DIALYSATE SIDE WAS CHARGED WITH WATER, ONE END OF THE DIALYSATE SIDE WAS CAPPED, AND AIR WAS APPLIED BY 1.5KGF/CM3.G FROM THE OTHER SIDE OF THE BLOOD SIDE. AIR BUBBLES WERE OBSERVED LEAKING FROM ONE OF THE SURFACE FIBERS AT THE ROOT OF THE URETHANE PART OF THE VENOUS SIDE. THIS DIALYZER WAS REPROCESSED BY THE CUSTOMER PROIR TO NOTING THE LEAK.

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTS A FIBER LAEK NOTED DURING INITIATION OF PATIENT TREATMENT. HEALTH CARE PROFESSIONAL REPORTS THE DIALYZER WAS REPLACED AND TREATMENT CONTINUED. HEALTH CARE PROFESSIONAL REPORTS AN ESTIMATE 0F 175CC BLOOD LOSS. HEALTH CARE PROFESSIONAL REPORTS THAT THE DIALYZER WAS REPROCESSED PRIOR TO THIS EVENT. HEALTH CARE PROFESSIONAL REPORTS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL CA-210 DIALYZER HOLLOW FIBER DIALYZERS FJI NISSHO . CA-210 A97K25

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN RENATRON REUSE DEVICE.