BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3936044 · Received June 23, 2014

    Report

    Report Number
    2937457-2014-01201
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 23, 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

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT CALLED IN WITH DRAIN COMPLICATIONS. DURING THIS CALL THE PATIENT STATED THAT SHE WAS BEING TREATED FOR PERITONITIS. A FOLLOW UP CALL WAS MADE TO THE PATIENT'S PERITONEAL DIALYSIS NURSE. THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2014. CULTURES CAME BACK WITH GRAM POSITIVE COCCI IN CLUSTERS. THE PATIENT INFORMED HER PERITONEAL DIALYSIS NURSE THAT SHE WAS NOT WEARING HER MASK DURING SET UP AS SHE HAD BEEN INSTRUCTED TO DO. THE PATIENT WAS TREATED WITH 2GM OF VANCOMYCIN INTRA PERITONEAL EVERY 5 DAYS FOR 21 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367061 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other LIBERTY TUBING, PD SOLUTION