BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS USA

    MDR report key: 278158 · Received May 10, 2000

    Report

    Report Number
    278158
    Event Type
    Other
    Date Received
    May 10, 2000
    Date of Event
    March 18, 2000
    Report Date
    March 20, 2000
    Manufacturer
    FRESENIUS USA
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VENOUS LINE TO VENOUS PERM CATH LOOSENED AND PT LOST APPROX 100CC BLOOD. STAFF MEMBER TRIED TO TIGHTEN CONNECTION BUT IT CAME LOOSE. BLOOD RETURNED TO PT & NEW SET-UP (LINES & DIALYZER STARTED). PT WAS GIVEN 1 UNIT OF PACKED RED BLOOD CELLS FOR HEMOGLOBIN 10.4. WILL REPEAT LABS HEMOGLOBIN ON TUESDAY 03/21/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS USA VENOUS BLOOD LINE FKJ FRESENIUS USA NA 9LR086

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other