BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS

    MDR report key: 277195 · Received May 11, 2000

    Report

    Report Number
    277195
    Event Type
    Death
    Date Received
    May 11, 2000
    Date of Event
    April 21, 2000
    Report Date
    April 24, 2000
    Manufacturer
    FRESENIUS USA
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VENOUS BLOOD LINE SEPARATION AT LOCK CONNECTION & ASH-SPLIT CATHETER RESULTING IN 250-450 CC BLOOD LOSS. PT STABLE AFTER TREATMENT WITH HGB 9.9 AND HCT 30. PT EXPIRED SAT. THE NEXT DAY, EARLY EVENING DURING SLEEP.LUER LOCK CONNECTION NOT HOLDING SEVERAL TIMES WHILE TESTING POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS VENOUS BLD LINE FKJ FRESENIUS USA * R8L060

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death