BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER

    MDR report key: 4252760 · Received November 13, 2014

    Report

    Report Number
    2937457-2014-03145
    Event Type
    Death
    Date Received
    November 13, 2014
    Date of Event
    February 23, 2013
    Report Date
    October 22, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PD NURSE STATED THAT THE PT'S DEATH WAS NO RELATED TO THE LIBERTY CYCLER. THERE WAS NO REPORTED ABNORMALITIES ASSOCIATED WITH THE PT'S PD TREATMENT. THERE WAS NO ADDITIONAL INFO. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT THE PD PT PASSED AWAY FROM A LARGE GASTROINTESTINAL BLEED. THE PT WAS NOT CONNECTED TO THE CYCLER AT THE TIME OF DEATH, HE HAD SUCCESSFULLY COMPLETED HIS TREATMENT ON HIS LIBERTY CYCLER THE NIGHT BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733539 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LIBERTY CYCLER SET| PD SOLUTIONS