BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 112036 · Received August 8, 1997

    Report

    Report Number
    2937457-1997-00049
    Event Type
    Other
    Date Received
    August 8, 1997
    Date of Event
    July 3, 1997
    Report Date
    July 8, 1997
    Manufacturer
    FRESENIUS USA, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS FACILITY REPORTED THAT APPROX 1/2 HR INTO THE DIALYSIS TREATMENT, A PT C/O NAUSEA AND VOMITING. PT WAS GIVEN SALINE AND WAS STABLE FOR ABOUT 1/2 HR. HE LATER C/O NAUSEA, VOMITING AND ABDOMINAL PAIN AND WAS SENT OT THE HOSP ER FOR EVAL. HIS DIAGNOSIS WAS ACIDOSIS AND HYPERKALEMIA. HE WAS DISCHARGED LATER ON THE SAME DAY.

    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 65 YR Hospitalization