BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4091634 · Received August 22, 2014

    Report

    Report Number
    2937457-2014-02269
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    April 21, 2014
    Report Date
    August 12, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL AND COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PT HAD CONTAMINATION PERITONITIS. THE FOLLOWING PERITONITIS WAS FOUND DURING REVIEW OF MEDICAL RECORDS PROVIDED BY THE PT'S TREATMENT FACILITY. A HOME VISIT WAS DONE BY THE PD NURSE AS F/U POST DIAGNOSIS OF PERITONITIS. THE PT HAD FINISHED ALL ANTIBIOTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508099 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention DELFLEX PD SOLUTIONS| LIBERTY CYCLER CASSETTE