BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 4110920 · Received September 8, 2014

    Report

    Report Number
    2937457-2014-02661
    Event Type
    Death
    Date Received
    September 8, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 12, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW, WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. 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

    IT WAS REPORTED THAT THE PT STARTED EXPERIENCING A RASH ON HIS BODY. ON (B)(6) 2014, THE RASH BECAME WORSE. SOMETIME LATER, DATE NOT REPORTED, THE PT EXPERIENCED PAIN ALL OVER. ON (B)(6) 2014, THE PT STOPPED TAKING HIS STEROIDS. ON (B)(6) 2014, THE PT CALLED PD NURSE AND STATED "HE WAS NOT FEELING WELL." ON (B)(6) 2014, THE PT WENT TO THE HOSP WITH LOW BLOOD PRESSURE AND ARRHYTHMIAS. CAUSE OF THE LOW BLOOD PRESSURE AND ARRHYTHMIAS WAS UNK. NO DETAILS OF THE PT'S TREATMENT WERE PROVIDED. REPORTEDLY, THE PT PASSED AWAY ON (B)(6) 2014, CAUSE OF DEATH WAS CARDIAC RELATED, BUT NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551328 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death