BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS DIALYZER

    MDR report key: 228149 · Received June 21, 1999

    Report

    Report Number
    228149
    Event Type
    Injury
    Date Received
    June 21, 1999
    Date of Event
    May 17, 1999
    Report Date
    June 14, 1999
    Manufacturer
    FRESENIUS USA
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS PLACED ON DIALYSIS AT 0647 AM. AT 0649 AM PT C/O FEELING HOT, SOB, DIZZY, NAUSEA AND ABDOMINAL PAIN. BLOOD PRESSURE ELEVATED 220/108. O2 PLACED ON PT. TREATMENT STOPPED. BLOOD NOT RETURNED. PT STABILIZED. REQUESTED TO GO TO BATHROOM. RETURNED AND WAS PLACED ON DRY DIALYZER. TREATMENT COMPLETED WITHOUT PROBLEM. ADMITTED TO HOSP AFTER TREATMENT FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYZER DIALYZER FII FRESENIUS USA F80B 8F 10208
    2 10% AMUCHIN-D, 10% DILUTION REPROCESSING SOLUTION LIF UNK * 5041

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization