BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3896227 · Received June 13, 2014

    Report

    Report Number
    2937457-2014-01037
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DEPT 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 MFR 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 PT REPORTED THAT SHE WAS ADMITTED TO A HOSP ON AN UNK DATE IN (B)(6) 2014, DUE TO AN EXACERBATION OF HER CONGESTIVE HEART FAILURE. NO PERITONEAL DIALYSIS TREATMENTS WERE MISSED AND THERE WAS NO REPORTABLE DEVICE MALFUNCTION. THE PT WAS DISCHARGED FROM THE HOSP ON (B)(6) 2014. AS ON (B)(6) 2014, THE PT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES, AND THE PT'S SIGNS AND SYMPTOMS OF CONGESTIVE HEART FAILURE EXACERBATION HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351164 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O DELFLEX PD SOLUTIONS| LIBERTY CYCLER CASSETTE