BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER

    MDR report key: 188326 · Received September 16, 1998

    Report

    Report Number
    2937457-1998-00036
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    August 26, 1998
    Report Date
    August 27, 1998
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN INFANT IN PEDIATRIC ICU REC'D AN OVERFILL OF PERITONEAL DIALYSIS SOLUTION IN DIFFERENT CYCLES. THE PRESCRIBED FILL VOLUME WAS 100 ML. THE OVERFILLS WERE BASED ON THE DRAIN VOLUMES (RANGING BETWEEN 210-340 ML) PER CYCLE AND THE AMOUNT OF SOLUTION LEFT IN THE BAGS AT THE END OF THE TREATMENT. THERE WAS NO SERIOUS INJURY OR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA FC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO