BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 4185014 · Received October 16, 2014

    Report

    Report Number
    2937457-2014-02986
    Event Type
    Death
    Date Received
    October 16, 2014
    Date of Event
    May 1, 2014
    Report Date
    October 15, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE MED RECORDS RECEIVED; THE RESULTS OF THE CLINICAL INVESTIGATION STATES IT IS UNLIKELY THAT THE LIBERTY CYCLER CAUSED OR CONTRIBUTED TO PT'S DEATH; AS SHE HAD MULTIPLE CO-MORBIDITIES INCLUDING MULTIPLE MYELOMA. PT HAD A HISTORY OF MULTIPLE MYELOMA AND FREQUENT HOSPITALIZATIONS; ADMITTED WITH PNEUMONIA, WHICH WAS COMPLICATED WITH SEPSIS. TRANSFER TO A HIGHER CARE HOSP WAS PLANNED, AND PT CODED AND DIED DURING TRANSPORT. A SERIOUS INJURY OF PT DEATH IS BEING REPORTED AS THE PT USED THE LIBERTY CYCLER FOR HER PD TREATMENTS. THE PT WAS NOT USING THE LIBERTY CYCLER AT THE TIME SHE EXPERIENCED A CARDIAC ARREST. THIS EVENT IS BEING FILED AS MDR REPORTABLE SERIOUS INJURY TO COMPLY WITH OUR REG COMMITMENT TO REPORT ANY SERIOUS INJURY WHILE USING A FRESENIUS DEVICE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH SEPSIS AND RESPIRATORY DISTRESS. ON (B)(6) 2014; THE PT WAS BEING TRANSFERRED FROM (B)(6) ED DUE TO HER DECLINING CONDITION. EN ROUTE THE PT WENT INTO CARDIAC ARREST, REQUIRING CHEST COMPRESSIONS AND INSERTION OF AN ORAL AIRWAY. THE PT CODED A TOTAL OF FOUR TIMES, HOWEVER, UPON ARRIVAL AND TREATMENT AT (B)(6) TRAUMA, SHE REGAINED SPONTANEOUS CIRCULATION. IT WAS SOON AFTER RESUSCITATION THE FAMILY AND ATTENDING PHYSICIAN AGREED UPON WITHDRAWING LIFE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656573 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death DELFLEX PD SOLUTIONS| LIBERTY CYCLER CASSETTE