BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CYCLER PD+

    MDR report key: 731698 · Received June 29, 2006

    Report

    Report Number
    2937457-2006-00005
    Event Type
    Injury
    Date Received
    June 29, 2006
    Report Date
    June 2, 2006
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS NURSE REPORTED THAT A PATIENT C/O BURNING SENSATION IN HER ABDOMEN AS SOON AS SHE STARTED HER CCPD TREATMENT. THE PATIENT WAS TAKEN TO THE HOSPITAL FOR DIAGNOSTIC TESTS AND WAS RELEASED LATER. THE NEXT MORNING, THE PATIENT NOTICED THAT ONE OF THE 5 LITER SOLUTION BAGS SHE USED FOR THE PREVIOUS NIGHT'S TREATMENT WAS VERY FULL. HER MOTHER TOOK IT TO THE DIALYSIS CLINIC TO BE EXAMINED. THE NURSE REPORTED THAT THE BAG WEIGHED 9 KG. THEY SUSPECTED THAT THE PUMP-TO-DRAIN MAY BE RUNNING BACKWARDS. IT IS UNKNOWN WHERE THE EXTRA SOLUTION CAME FROM. LABORATORY TESTS SHOWED THAT IT WAS POSITIVE FOR BUN AND CREATININE. THE PATIENT SYMPTOMS CLEARED AND HAD NO FURTHER SYMPTOMS WHEN SHE WAS RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM CYCLER PD+ PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA NEWTON IQ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization