BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 113274 · Received August 13, 1997

    Report

    Report Number
    2937457-1997-00051
    Event Type
    Other
    Date Received
    August 13, 1997
    Date of Event
    July 22, 1997
    Report Date
    July 22, 1997
    Manufacturer
    FRESENIUS USA, INC
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS FACILITY REPORTED THAT A PT BECAME HYPOTENSIVE DURING A DIALYSIS TREATMENT AND WAS GIVEN A TOTAL OF 2150 ML OF SALINE. THERE WAS REPORTEDLY AN EXCESSIVE FLUID REMOVAL OF 2.6 KG. THE PT WAS ADMITTED TO THE HOSPITAL FOR HYPOTENSION AND SHORTNESS OF BREATH. THERE WAS NO SERIOUS PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FII FRESENIUS USA, INC 2008E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization