BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTERIAL POST W LUER LOCKS DW 480

    MDR report key: 37973 · Received September 10, 1996

    Report

    Report Number
    8030665-1996-00267
    Event Type
    Death
    Date Received
    September 10, 1996
    Report Date
    August 22, 1996
    Manufacturer
    NMC MPD
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ARTICLE ALLEGED: ALTHOUGH NOT OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSED BY KINKED BLOOD LINES, WHEN A PT AFTER COMPLETION OF 4 HOUR DIALYSIS SESSIONS, COMPLAINED OF ABDOMINAL PAIN, NAUSEA, DIC, GI BLEED, PANCREATITIS. PT WAS HOSPITALIZED AND EXPIRED. COMPLAINTS OF THIS NATURE WERE INVESTIGATED UNDER FIR 93015. PRODUCT #0392035 UNDER SAME COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL POST W LUER LOCKS DW 480 BLOOD LINE FJK NMC MPD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death| H| L| R