BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 3969917 · Received April 25, 2014

    Report

    Report Number
    2937457-2014-00714
    Event Type
    Other
    Date Received
    April 25, 2014
    Date of Event
    March 29, 2014
    Report Date
    March 30, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    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. ON (B)(4) 2014, THE PT EXPERIENCED AN EPISODE OF INCREASED INTRAPERITONEAL VOLUME (IIPV) WHERE IN DRAIN ZERO, THE PT EXPRESSED 4123ML OF EFFLUENT FROM HER PERITONEAL DIALYSIS CATHETER. THE LAST FILL VOLUME OF HER PREVIOUS TREATMENT WAS A 2000ML DWELL. THE OT WAS ASYMPTOMATIC AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. AS OF (B)(6) 2014. THE PT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES. 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 PERITONEAL DIALYSIS (PD) PT REPORTED EXPERIENCING DRAIN ISSUES DURING TREATMENT ON (B)(6) 2014. THE PT REMAINED ASYMPTOMATIC: LAST FILL VOLUME: 2000ML DWELL. DRAIN ZERO: 4123ML. THE REPORTED DRAIN VOLUME OF 4123ML WAS 206% OVER THE EXPECTED DRAIN VOLUME WHICH RESULTED IN A REPORTABLE DEVICE MALFUNCTION. THE PT DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THE OVER-FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250797 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER CASSETTE