BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 293569 · Received August 28, 2000

    Report

    Report Number
    2937457-2000-00049
    Event Type
    Malfunction
    Date Received
    August 28, 2000
    Date of Event
    July 31, 2000
    Report Date
    July 31, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE FAMILY MEMBER OF A HOME PERITONEAL DIALYSIS PT REPORTED THAT THE PT COMPLAINED OF DIFFICULTY BREATHING AND STARTED SCREAMING DURING FILL 1. THE FILL VOLUME DISPLAYED WAS FLUCTUATING AND WENT NEGATIVE. PT CALLED THE NURSE AND WAS INSTRUCTED TO DRAIN. THE DRAIN VOLUME SHOWN WAS ABOUT 4,700 ML. THE PRESCRIBED FILL VOLUME WAS 1,500 ML. THE PT WAS FINE AFTER DRAINING. THERE WAS NO SERIOUS PT INJURY AND NO MEDICAL INTERVENTION WAS NECESSARY.

    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 81 YR