BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3820742 · Received May 8, 2014

    Report

    Report Number
    2937457-2014-00793
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 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 PHYSICIAN'S ASSESSMENT OF THE REPORTED INFORMATION AND COMPLETION OF THE PLANT'S INVESTIGATION. RELATED MDRS: 8030665-2014-00363 AND 1713747-2014-99963.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED EXPERIENCING DRAIN COMPLICATIONS. ONE DAY LATER THE PD NURSE CONFIRMED THAT THE PATIENT WAS HOSPITALIZED WITH PERITONITIS ON (B)(6) 2014. THE PATIENT'S WIFE REPORTED THAT THE PATIENT'S CATHETER WAS BLOCKED COMPLETELY. MEDICAL RECORDS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279663 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LIBERTY CYCLER CASSETTE| DELFLEX PD SOLUTIONS