BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4091635 · Received August 22, 2014

    Report

    Report Number
    2937457-2014-02268
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    June 30, 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 A PT HAD SEVERAL LAB RESULTS SHOWING INCREASED WHILE BLOOD CELL COUNTS (WBC) IN HER PD FLUID, WITHOUT HAVING A POSITIVE CULTURE. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S TREATMENT FACILITY. THE PT HAD A CONFIRMED COAGULASE (B)(6) CONTAMINATION PERITONITIS ON (B)(6) 2014. THE PT WAS TREATED WITH VANCOMYCIN 2G AND CEFTAZIDIME 1G INTRA-PERITONEAL. THE PT HAS ALSO HAD GASTRO-INTESTINAL SYMPTOMS OF DIARRHEA AND CONSTIPATION. NO FURTHER COMPLICATIONS HAVE OCCURRED AND THE SHE HAS BEEN ABLE TO CONTINUE WITH HER PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508085 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