BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSA F80A (HF/PS/1.8/H)

    MDR report key: 221093 · Received April 27, 1999

    Report

    Report Number
    1713747-1999-00153
    Event Type
    Injury
    Date Received
    April 27, 1999
    Date of Event
    April 12, 1999
    Report Date
    April 26, 1999
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FMC COMPLAINT REC'D FOR EVAL. STATED COMPLAINT IS "WITH EIGHT MINUTES REMAINING OF TREATMENT, BLOOD LEAK ALARM NOTED." BLOOD LOSS REPORTED AS 250 CC. INTERNAL BLOOD LEAK. NO SAMPLE IS AVILABLE AND LOT NUMBER IS UNK. FURTHER CLARIFICATION OF INFO SUBMITTED HAS BEEN REQUESTED BY QS FROM CANADA. MDR FILED DUE TO BLOOD LOSS REPORTED. 4/27/99 NO FURTHER INFO IS AVAILABLE FROM CUSTOMER. REPORTED BLOOD LOSS WAS DUE TO DISCARD OF THE EXTRACOPOREAL CIRCUIT; MDR FILED BASED ON THIS BLOOD LOSS. NO PT INJURY OR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSA F80A (HF/PS/1.8/H) HIGH FLUX DIALYZER KDI FRESENIUS F80A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other NON-REUSE.