BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 491846 · Received October 22, 2003

    Report

    Report Number
    2937457-2003-00030
    Event Type
    Malfunction
    Date Received
    October 22, 2003
    Date of Event
    September 26, 2003
    Report Date
    October 1, 2003
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT WAS OVERFILLED DURING TREATMENT. THE CYCLER GAVE A SCALE 9 ALARM DURING DRAIN 1 WHICH IS UNEXPECTED AT THIS PHASE. THEY RESET THE ALARM AND THE CYCLER WENT BACK TO THE PRIMING SCREEN. THE PT COMPLAINED OF SHORTNESS OF BREATH. THE FAMILY MEMBER TURNED THE CYCLER OFF AND DRAINED THE PT MANUALLY. DRAIN VOLUME WAS EQUAL TO TWO 3-LITER BAGS. THE PT'S PRESCRIBED FILL VOLUME IS 2 LITERS. PT FELT BETTER AFTER DRAINING. THERE WAS NO SERIOUS INJURY.

    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+ IQCARD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR