BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY DIALYSIS CYCLER

    MDR report key: 3950927 · Received July 14, 2014

    Report

    Report Number
    2937457-2014-01636
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 13, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS HAVE BEEN REQUESTED AND HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. AT THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE CLINICAL AND PLANT INVESTIGATIONS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT DRAIN COMPLICATION OCCURRED DURING TREATMENT. NURSE STATED THAT PATIENT HAD PERITONITIS AROUND THAT TIME WAS THE CAUSE OF THE DRAIN COMPLICATIONS. PATIENT'S NURSE STATED THAT THE PATIENT HAD PERITONITIS DUE TO TOUCHING THE END OF HER CATHETER; TOUCH CONTAMINATION. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410158 LIBERTY DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R LIBERTY DIALYSIS TUBING| PD SOLUTIONS