BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSA F80B (HF/PS/1.8/H)

    MDR report key: 245249 · Received October 15, 1999

    Report

    Report Number
    1713747-1999-00288
    Event Type
    Injury
    Date Received
    October 15, 1999
    Date of Event
    August 14, 1999
    Report Date
    October 13, 1999
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED A MINOR BLOOD LEAK AT THE END OF TREATMENT. ESTIMATED BLOOD LOSS 252CC. AS VERIFIED WITH RN, THERE WERE NO ADVERSE EFFECTS TO THE PT AND NOMEDICAL INTERVENTION WAS REQUIRED. MDR FILED DUE TO BLOOD LOSS. DIALYZER WAS NOT SAVED FOR EVAL.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other RENAL SCIENTIFIC REUSE CART/FORMALIN/FRESENIUS| 2008H.