BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL

    MDR report key: 3761050 · Received April 11, 2014

    Report

    Report Number
    8030665-2014-00288
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    January 4, 2014
    Report Date
    March 26, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION. RELATED MDRS: 2937457-2014-00562 AND 1713747-2014-99946.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED A PATIENT DEVELOPED PERITONITIS. THE PATIENT PRESENTED WITH CLOUDY EFFLUENT AND WAS TREATED WITH VANCOMYCIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220916 LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL FKX FRESENIUS MEDICAL CARE NORTH AMERICA 13LR08114

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention DELFLEX| LIBERTY CYCLER