BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 279838 · Received May 23, 2000

    Report

    Report Number
    2937457-2000-00030
    Event Type
    Malfunction
    Date Received
    May 23, 2000
    Date of Event
    April 26, 2000
    Report Date
    April 26, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SPOUSE OF A HOME PERITONEAL DIALYSIS PT REPORTED THAT DURING FILL 1, PT COMPLAINED OF SHORTNESS OF BREATH. SPOUSE DID NOT REMEMBER WHAT THE DISPLAYED FILL VOLUME WAS. SPOUSE TURNED THE CYCLER OFF AND THEN ON AGAIN TO DRAIN THE PT. THE DRAIN VOLUME WAS 5,630 ML. THE PRESCRIBED FILL VOLUME WAS 2 LITERS. THE PT FELT BETTER AFTER DRAINING. 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 79 YR