BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 376557 · Received February 7, 2002

    Report

    Report Number
    2937457-2002-00008
    Event Type
    Malfunction
    Date Received
    February 7, 2002
    Date of Event
    December 8, 2001
    Report Date
    January 8, 2002
    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 MOTHER OF A HOME PERITONEAL DIALYSIS PATIENT REPORTED THAT THE PATIENT RECEIVED AN OVERFILL OF SOLUTION DURING FILL 1. THE PATIENT C/O PAIN IN THE STOMACH SO PATIENT BYPASSED TO DRAIN. THE DRAIN VOLUME SHOWN WAS 3,390 ML. THE FILL VOLUME IN FILL 1 WAS 1,120 ML. THE PATIENT FELT RELIEVED 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 15 YR