BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS USA

    MDR report key: 454968 · Received April 10, 2003

    Report

    Report Number
    454968
    Event Type
    Death
    Date Received
    April 10, 2003
    Date of Event
    April 2, 2003
    Report Date
    April 4, 2003
    Manufacturer
    FRESENIUS USA
    Product Code
    FID
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOUND BEND IN ARTERIAL LINE WHEN PT HAD BEEN ON TX 1HR 25MIN. CORRECTED BEND. 10 MINUTES LATER PT BECAME SYMPTOMATIC WITH VOMITING. HYPERTENSION HAD BEEN PRESENT ALSO. SYSTEM RECIRCULATED UNTIL PHYSICIAN ORDER TO RESTART WAS RECEIVED. 0.2MG CLONIDINE PO WAS GIVEN. PT VOMITED AGAIN AND PHYSICIAN ORDERED SUPPLEMENTAL DOSE. TREATMENT DISCONTINUED EARLY DUE TO CONTINUED NAUSEA/VOMITING AND CYANOSIS. CYANOSIS BECAME WORSE IN SPITE OF INCREASED OXYGEN TO 3 LNC. VOMITING CONTINUED. PT SENT TO ER PER PHYSICIAN ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS USA ARTERIAL BLOOD LINE FID FRESENIUS USA 03-7630-1 1 LR 082 A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H VENOUS BLOODLINE, F80M DIALYZER.