BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3980021 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01597
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 4, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (HYPOCALEMIA). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL STAFF AND COMPLETION OF THE PLAINTIFF'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT'S DAUGHTER REPORTED THE PT WAS HOSPITALIZED. A FOLLOW UP CALL WAS MADE TO THE PT'S PERITONEAL DIALYSIS NURSE. THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 FOR PNEUMONIA, HYPOGLYCEMIA AND HYPOCALEMIA. THE PT WAS DISCHARGED ON (B)(6) 2014 TO A NURSING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370952 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR LIBERTY TUBING| PD SOLUTION