BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 276825 · Received May 5, 2000

    Report

    Report Number
    2937457-2000-00028
    Event Type
    Malfunction
    Date Received
    May 5, 2000
    Date of Event
    April 13, 2000
    Report Date
    April 13, 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

    DURING EVAL OF A CYCLER FOR A NON-REPORTABLE PROBLEM, MFR FOUND THAT CYCLER WAS DELIVERING INACCURATE VOLUMES TO THE PSEUDO PT. THE CYCLER WAS SHOWING THAT THE PROGRAMMED FILL VOLUME WAS DELIVERED, BUT THE DRAIN VOLUMES WERE UNUSUALLY HIGH. THE HIGHEST DRAIN VOLUME WAS APPROXIMATELY 194% OF THE PROGRAMMED FILL VOLUME.

    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