BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 275570 · Received April 25, 2000

    Report

    Report Number
    2937457-2000-00023
    Event Type
    Malfunction
    Date Received
    April 25, 2000
    Date of Event
    March 15, 2000
    Report Date
    March 15, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A PERITONEAL DIALYSIS NURSE STATING THAT THE CYCLER WAS SHOWING NEGATIVE NUMBERS WHILE IN DRAIN 0 BUT IT WAS DRAINING THE SOLUTION PROPERLY. NO OTHER PROBLEM WAS REPORTED SINCE THE TREATMENT WAS TERMINATED. THIS REPORT DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT OR MALFUNCTION. INVESTIGATION OF THE CYCLER ON 4/17/00 SHOWED NEGATIVE NUMBERS IN DRAIN 0 AND FILL 1. THE CYCLER DELIVERED MORE SOLUTION TO THE PSEUDO PT THAN THE PROGRAMMED AMOUNT OF 2,200 ML. THE MEASURED FILL VOLUME WAS 3,992 ML. MDR DETERMINATION WAS BASED ON THE RESULTS OF THE DEVICE EVALUATION.

    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 NA