BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 4252759 · Received November 13, 2014

    Report

    Report Number
    2937457-2014-03144
    Event Type
    Death
    Date Received
    November 13, 2014
    Report Date
    September 29, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNK. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, THE INITIAL REPORTED ISSUE OF DRAIN COMPLICATION WAS RESOLVED DURING THE TECHNICAL SUPPORT CALL. BASED OFF OF THE INVESTIGATION OF THE EVENT, THE REPORTED ISSUE WAS UNRELATED TO THE DEVICE, BUT NO ADDITIONAL INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    THE PERITONEAL DIALYSIS (PD) PT'S CONTACT REPORTED DRAIN COMPLICATIONS DURING PD TREATMENT ON THE LIBERTY CYCLER. DURING A FOLLOW-P ATTEMPT, THE PD NURSE REPORTED THAT THE PT HAD PASSED AWAY OVER A YEAR AGO DUE TO CARDIAC ARREST SECONDARY TO CARDIOMYOPATHY ISCHEMIA. THE NURSE REPORTED THAT THE EVENT WAS UNRELATED TO THE LIBERTY CYCLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732804 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 Death