BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSA F80B (HF/PS/1.8/H)

    MDR report key: 184047 · Received August 24, 1998

    Report

    Report Number
    1713747-1998-00849
    Event Type
    Injury
    Date Received
    August 24, 1998
    Date of Event
    July 21, 1998
    Report Date
    July 27, 1998
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED AN INTERNAL FIBER LEAK ON THE 12TH USE DIALYZER AFTER 15 MINUTES OF TREATMENT. ESTIMATED BLOOD LOSS TO THE PT WAS 250CC. THE ENTIRE CIRCUIT WAS CHANGED, NO BLOOD WAS RETURNED. THE SAMPLE IS AVAILABLE FOR EXAMINATION. HEMOGLOBIN PRE-INCIDENT WAS 11.1 AND THE HEMATOCRIT WAS 35.7. NO POST-INCIDENT DATA IS AVAILABLE. PT FINISHED TREATMENT WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSA F80B (HF/PS/1.8/H) HIGH FLUX DIALYZER KDI FRESENIUS F80B 8D13508

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R INCUBATION X 24 HOURS| HEMODIALYSIS 3XWEEK/ FORMALDEHYDE < 1.0%,