BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 297768 · Received September 20, 2000

    Report

    Report Number
    2937457-2000-00052
    Event Type
    Malfunction
    Date Received
    September 20, 2000
    Date of Event
    September 1, 2000
    Report Date
    September 1, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE SPOUSE OF A HOME PERITONEAL DIALYSIS PT REPORTED THAT THE PT WAS FEELING VERY DISTENDED WHEN PT WOKE UP AFTER A "CCPD" TREATMENT. SPOUSE NOTICED THAT THE SOLUTION BAGS ON THE CYCLER WERE EMPTY BUT DOES NOT RECALL ANY ALARM. THERE IS USUALLY SOME SOLUTION LEFT AFTER THE TREATMENT. SPOUSE DRAINED THE PT AND WAS ABLE TO DRAIN ABOUT 4,700 ML. PT'S PRESCRIBED FILL VOLUME IS 2,100 ML. THE PT FELT BETTER AFTER DRAINING. THERE WAS NO SERIOUS INJURY AND NO MEDIAL 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 85 YR