BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3233906 · Received July 16, 2013

    Report

    Report Number
    2937457-2013-00094
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL HAS NOT YET BEEN COMPLETED. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. ADD'L ATTEMPTS TO THE INITIAL REPORTER HAVE BEEN MADE WITH NO ADD'L INFO PROVIDED. THIS MDR INCLUDES ALL EVENT INFO RECEIVED TO DATE. DUE TO THE LACK OF ADD'L INFO AND THE KNOWN COMPLICATION OF PERITONITIS DUE TO A FLUID LEAK, THIS MDR IS BEING FILED AS A SERIOUS INJURY. THIS MEDWATCH REPORT IS ASSOCIATED WITH MDR # 8030665-2013-00450.

    Description of Event or Problem · 1

    A USER FACILITY HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. TECH STATED THAT FLUID WAS FOUND IN THE CYCLER AFTER TREATMENT WHEN THE CASSETTE DOOR WAS OPEN. TECH COULD NOT IDENTIFY LEAK LOCATION. THE TECH ALSO RECALLED THAT THE PT WAS ALREADY ON A REGIMENT OF ANTIBIOTICS WHEN THE LEAK OCCURRED. THERE IS NO KNOWN PT EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329377 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

    Patients

    Seq Age Sex Outcome Treatment
    1 PD SOLUTION| LIBERTY CYCLER SET