BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3821308 · Received May 9, 2014

    Report

    Report Number
    2937457-2014-00797
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    February 20, 2014
    Report Date
    April 10, 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 FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL (PD) NURSE REPORTED THAT THE PT WAS ADMITTED ON (B)(6) 2014 FOR ENCEPHALOPATHY OF UNK ETIOLOGY. THE PT PRESENTED WITH A COUPLE DAY HISTORY OF NAUSEA AND VOMITING WITH ABDOMINAL DISCOMFORT AND ALTERED LEVEL OF CONSCIOUSNESS. SHE WAS TREATED FOR DEHYDRATION AND HYPOKALEMIA. DUE TO THE LEUKOCYTOSIS THE ETIOLOGY OF THE OF INFECTION WAS BEING LOOKED FOR A RULED OUT UREMIC ENCEPHALOPATHY. THE PT HAD HAD GOOD CLEARANCES. THE PT WAS DISCHARGED (B)(6) 2014 AND WAS CONTINUING WITH HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282147 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization LEVEMIR| NORVASC| ZOSYN| AMIODARONE| LIBERTY CYCLER CASSETTE| OXYGEN AT NIGHT| SIMVASTATIN| GLIPIZIDE| PRADAXA| AMIODARONE| DELFLEX PD SOLUTIONS| LASIX| ASPIRIN| CEPHALEXIN| ROCALTROL| HYDRALAZINE| ZOFRAN