BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS MEDICAL CARE

    MDR report key: 287845 · Received July 18, 2000

    Report

    Report Number
    287845
    Event Type
    Injury
    Date Received
    July 18, 2000
    Date of Event
    June 6, 2000
    Report Date
    June 12, 2000
    Manufacturer
    FMC
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER INITIATION OF DIALYSIS TREATMENT A SEPARATION OCCURRED AT THE JUNCTION OF THE VENOUS BLOODLINE AND THE CENTRAL VENOUS CATHETER RESULTING IN BLOODLOSS > 400CC AND AIR ENTERING THE CENTRAL VENOUS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS MEDICAL CARE VENOUS BLOODLINE FKJ FMC VENOUS BLOOD LINE 95R055

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization ASH SPLIT CATHETER (MEDCOMP) 06/09/2000