BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRES F80M (HF/PS/1.8/M)

    MDR report key: 227698 · Received April 29, 1999

    Report

    Report Number
    9611823-1999-00133
    Event Type
    Injury
    Date Received
    April 29, 1999
    Date of Event
    February 22, 1999
    Report Date
    April 5, 1999
    Manufacturer
    FRESENIUS MEDICAL CARE DEU
    Product Code
    KDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTICE OF COMPLAINT CONCERNING ABOVE PRODUCT FROM PRODUCT COMPLAINT FORM FILED BY FACITILY. CLINIC REPORTS A BLOOD LEAK AT THE INITIATION OF THE TREATMENT AT DIALYZER REUSE #2. UNABLE TO MAKE CONTACT WITH FACILITY UNTIL 4-5-99. CALLED FACILITY AND WAS NOTIFIED OF EBL.250CCSTHERE WERE NO ADVERSE EFFECTS TO PATIENT OR MEDICAL INTERVENTION REQUIRED. SAMPLE WAS DISCARDED ON DAY OF TREATMENT, THEREFORE THERE IS NO SAMPLE AVAILABLE. MDR FILED DUE TO BLOOD LOSS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRES F80M (HF/PS/1.8/M) MEDIUM FLUX DIALYZER KDI FRESENIUS MEDICAL CARE DEU F80M IKC021

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other FORMALDEHYDE/BLEACH.| FRESENIUS SOLUTION, ALTHIN MACHINE, REUSE UTILIZES