BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 279841 · Received May 23, 2000

    Report

    Report Number
    2937457-2000-00029
    Event Type
    Malfunction
    Date Received
    May 23, 2000
    Date of Event
    May 11, 2000
    Report Date
    May 11, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FAILURE INVESTIGATION OF A PERITONEAL DIALYSIS CYCLER RETURNED FOR A NON REPORTABLE PROBLEM SHOWED THAT IT DELIVERED AN EXCESSIVE AMOUNT OF SOLUTION DURING A SIMULATED TREATMENT. THE FILL VOLUME DISPLAYED ON THE CYCLER WAS 2.650 ML, BUT THE MEASURED VOLUME WAS 6,935 ML. THE SCALE WAS FOUND TO BE INACCURATE.

    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 NA