BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS

    MDR report key: 263811 · Received February 17, 2000

    Report

    Report Number
    263811
    Event Type
    Injury
    Date Received
    February 17, 2000
    Date of Event
    February 3, 2000
    Report Date
    February 14, 2000
    Manufacturer
    FMC
    Product Code
    FJK
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT APPROX 3 HRS AND 10 MINS INTO THE DIALYSIS TREATMENT, THE PT STARTED TO COMPLAIN OF SEVERE ABDOMINAL PAIN. DENIED NAUSEA AND VOMITTING AT THIS TIME. AT 10:OO PT THEN BECAME NAUSEATED AND DID VOMIT YELLOW/GREEN FLUID. PT FELT MUCH BETTER. BLOOD PRESSURE AT 9:40 WAS 194/94, PULSE 61. BLOOD PRESSURE AT 10:00 WAS 231/105, PULSE 66. NURSE PRACTITIONER INFORMED. ORDERS GIVEN TO DRAW AMYLASE, LIPASE. HEPATIC PANEL TO "RUSH LAB". UPON DISCHARGE PT FELT MUCH BETTER WITH SLIGHT ABDOMINAL CRAMPING. PT INSTRUCTED TO GO TO ER IF PAIN ENSUES - PT WAS ADMITTED TO HOSP EARLIER IN THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS HEMODIALYSIS BLOOD LINE FJK FMC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L 1. FRES. VENOUS BLOOD LINE,| 2. FRES. F8 DIALYZER,| 3. FRES. 2008H MACHINE.