BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 283471 · Received June 22, 2000

    Report

    Report Number
    2937457-2000-00038
    Event Type
    Malfunction
    Date Received
    June 22, 2000
    Report Date
    May 23, 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 CYCLER RETURNED FOR A NON-REPORTABLE PROBLEM SHOWED THAT THE CYCLER DELIVERED UP TO 1,351 ML. MORE THAN THE PROGAMMED FILL VOLUME DURING A SIMULATED TREATMENT.

    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 *