BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PT CONNECT

    MDR report key: 3834584 · Received May 2, 2014

    Report

    Report Number
    8030665-2014-00343
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PHYSICIAN'S ASSESSMENT OF THE REPORTED INFO AND COMPLETION OF THE PLANT'S INVESTIGATION. RELATED MDRS: 2937457-2014-00745, 8030665-2014-00343 AND 1713747-2014-99956.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED A PT WAS HOSPITALIZED FOR A COUPLE OF DAYS FOR LOW BLOOD SUGAR. SHE STATED THIS WAS NOT CYCLER RELATED. MED RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265283 LIBERTY CYCLER SET, DUAL PT CONNECT FKX REYNOSA MANUFACTURING 13SR08018

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LIBERTY CYCLER