BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOUS LINE BAX 350/450/550/1550;COBE C

    MDR report key: 279018 · Received May 16, 2000

    Report

    Report Number
    8030665-2000-00157
    Event Type
    Death
    Date Received
    May 16, 2000
    Date of Event
    April 21, 2000
    Report Date
    April 25, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    CLINIC REPORTS THAT A VENOUS BLOODLINE SEPARATION AT THE LUER LOCK CONNECTION OF THE ASH SPLIT CATHETER OCCURRED RESULTING IN A 250-450CC BLOOD LOSS. THE CATHETER WAS IMPLANTED IN 1999. THE MACHINE DID ALARM. PT WAS INITIALLY STABLE, BUT LATER EXPIRED. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS LINE BAX 350/450/550/1550;COBE C BLOODLINE FKJ ERIKA DE REYNOSA R8L060

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| O