BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 272880 · Received April 7, 2000

    Report

    Report Number
    2937457-2000-00016
    Event Type
    Malfunction
    Date Received
    April 7, 2000
    Date of Event
    March 9, 2000
    Report Date
    March 9, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOME PERITONEAL DIALYSIS NURSE REPORTED THAT A PT RECEIVED AN OVERFILL OF SOLUTION DURING PT'S FIRST TREATMENT AT HOME. DURING FILL 1, THE FILL VOLUME WAS INCREMENTING SLOWLY. THE LOWER VALVE BOX WAS ALSO NOTED TO BE CYCLING CONTINUOUSLY. THE PT COMPLAINED OF "BELLY ACHE" AND THE NURSE NOTICED THAT THE TWO 5 LITER BAGS APPEARED 1/2 EMPTY. THE PT WAS DRAINED AND THE ESTIMATED DRAIN VOLUME WAS 3,500-4,000 ML. PT'S PRESCRIBED FILL VOLUME WAS 1,300 ML. THERE WAS NO SERIOUS INJURY OR ILLNESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR