BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 473414 · Received July 18, 2003

    Report

    Report Number
    2937457-2003-00026
    Event Type
    Malfunction
    Date Received
    July 18, 2003
    Date of Event
    June 24, 2003
    Report Date
    June 24, 2003
    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 PATIENT WAS OVERFILLED. DURING FILL 1, THE CYCLER GAVE AN ALARM. THE VOLUME WAS ONLY 1,650 ML. BUT THE PATIENT COMPLAINED OF STOMACH PAIN. THEY BYPASSED TO DRAIN AND THE FIRST DRAIN WAS 1,020 ML. THE PATIENT WAS STILL COMPLAINING OF DISCOMFORT SO THEY BYPASSED THE NEXT FILL AND DWELL, AND DRAINED ANOTHER 5,470 ML. THE PATIENT'S PRESCRIBED FILL VOLUME WAS 2,500 ML. PATIENT FELT SOME RELIEF AFTER THE SECOND DRAIN. TREATMENT WAS CONTINUED BUT THE LAST FILL WAS INCOMPLETE SINCE THEY RAN OUT OF SOLUTION. 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 81 YR