BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS VENOUS BLOOD LINE

    MDR report key: 287399 · Received July 24, 2000

    Report

    Report Number
    287399
    Event Type
    Injury
    Date Received
    July 24, 2000
    Date of Event
    June 29, 2000
    Report Date
    July 5, 2000
    Manufacturer
    FRESENIUS USA
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN RESPONDING TO MACHINE ALARM IT WAS NOTICED THAT THE VENOUS LINE BECAME SEPARATED FROM THE TESIO CATHETER. PT LOST APPROX 500 CC BLOOD AND BECAME UNRESPONSIVE WITH AGONAL RESPIRATIONS. PT WAS BOLUSED WITH NORMAL SALINE AND TRANSPORTED TO HOSP VIA 911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS VENOUS BLOOD LINE BLOOD LINE FKJ FRESENIUS USA 0373035 9KR031

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization DIALYZER,| TESSIO CATHETER,| FRESENIUS H MACHINE.