BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NMC FREEDOM CYCLER

    MDR report key: 34492 · Received May 16, 1996

    Report

    Report Number
    54354-1996-00168
    Event Type
    Injury
    Date Received
    May 16, 1996
    Date of Event
    May 15, 1996
    Report Date
    May 16, 1996
    Manufacturer
    FRESENIUS USA
    Product Code
    KPF
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT'S SON REPORTED THAT ON THE FIRST EXCHANGE THE PT COMPLAINED OF EXTREME PAIN AND NOT BEING ABLE TO BREATHE. THE PT WAS TAKEN TO THE EMERGENCY ROOM AND THEY DRAINED OUT 5000ML OF SOLUTION FROM HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NMC FREEDOM CYCLER PERITONEAL DIALYSIS MACHINE KPF FRESENIUS USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization