BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3980035 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01608
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DEPARTMENT HAS REQUESTED MEDICAL RECORDS AND INVESTIGATIONS ARE PENDING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN MEDICAL RECORDS ARE RECEIVED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT EXPERIENCED A STROKE ON AN UNKNOWN DATE IN (B)(6) 2014. THE PATIENT WAS NOT DIALYZING AT THE TIME OF THE EVENT. NO PERITONEAL DIALYSIS TREATMENTS WERE MISSED AND THERE WAS NO REPORTABLE DEVICE MALFUNCTION. AS OF 05/10/2014, THE PATIENT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY, AND IT IS UNKNOWN IF THE PATIENT CONTINUES TO EXPERIENCE SIGNS AND SYMPTOMS OF A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372196 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other DELFLEX PD SOLUTION| LIBERTY CYCLER CASSETTE