BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 300922 · Received October 17, 2000

    Report

    Report Number
    2937457-2000-00055
    Event Type
    Injury
    Date Received
    October 17, 2000
    Date of Event
    September 18, 2000
    Report Date
    September 18, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS NURSE REPORTED THAT A PT WENT INTO RESPIRATORY ARREST DURING A CHRONIC CONTINUOUS PERITONEAL DIALYSIS TREATMENT IN THE HOSP. THE DIALYSIS NURSE SET UP THE CYCLER AND THE FAMILY REQUESTED TO BE INSTRUCTED ON HOW TO BYPASS AND TROUBLESHOOT ALARMS. THE CYCLER DATA SHEET INDICATES THAT THE PT DID NOT DRAIN ALL THE SOLUTION IN DRAIN 0, WAS FILLED AGAIN WITH 2,410 ML. OF SOLUTION IN FILL 1 AND THEREFORE HAD A LARGE DRAIN VOLUME (4,900 ML) IN DRAIN 1. THE NURSE BELIEVES THAT THE PT OR FAMILY MAY HAVE BYPASSED DRAIN 0 AND ADVANCED TO FILL 1. THE CAUSE OF THE RESPIRATORY ARREST COULD NOT BE DETERMINED.

    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 69 YR