BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 273682 · Received April 10, 2000

    Report

    Report Number
    2937457-2000-00020
    Event Type
    Malfunction
    Date Received
    April 10, 2000
    Date of Event
    March 7, 2000
    Report Date
    March 11, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE REPORTED THAT WHILE PERFORMING SIMULATED TREATMENTS DURING A HOME PT TRAINING, THE CYCLER DISPLAYED NEGATIVE NUMBERS. THE DATA SHEET SHOWED A FILL 1 VOLUME OF 810 AND A DRAIN 1 VOLUME OF 830 WITH A PROGRAMMED FILL OF 500 ML. THERE WAS NO PT INVOLVEMENT.

    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