BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 106682 · Received July 16, 1997

    Report

    Report Number
    2937457-1997-00040
    Event Type
    Other
    Date Received
    July 16, 1997
    Date of Event
    June 16, 1997
    Report Date
    June 16, 1997
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS FACILITY REPORTED THAT A MACHINE REMOVED TOO MUCH FLUID FROM A PT. THE PT. BECAME HYPOTENSIVE AND C/O CRAMPS DURING THE TREATMENT. HE WAS GIVEN A TOTAL OF 1150 CC. OF NORMAL SALINE AND 5 CC. OF HYPERTONIC SALINE. HE WAS ALSO C/O WEAKNESS POST TX. AND HIS CONDITION DID NOT IMPROVE SO HE WAS TAKEN TO THE HOSP FOR OVERNIGHT OBSERVATION., HE WAS DISCHARGED THE NEXT DAY AND RETURNED FOR HIS REGULAR DIALYSIS TREATMENTS PER SCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FII FRESENIUS MEDICAL CARE NORTH AMERICA 2008D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization