BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3862799 · Received May 28, 2014

    Report

    Report Number
    2937457-2014-00896
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 30, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PHYSICIAN'S ASSESSMENT OF THE REPORTED INFORMATION AND THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT ON (B)(6) 2014, SHE FELL SHORT OF BREATH. SHE THEN DID A MANUAL DRAIN AND DRAINED APPROXIMATELY 1500 ML. THE PATIENT FELT SICK, SO SHE WENT TO THE HOSPITAL. AT THE HOSPITAL, ANOTHER DRAIN WAS DONE OF 3400ML FOR A TOTAL OF 4900ML. HER NORMAL FILL VOLUME IS 2500ML. THE PATIENT WAS IN HOSPITAL FOR A COUPLE OF DAYS AND WAS DISCHARGED ON (B)(6) 2014. THE PATIENT HAS BEEN USING MANUAL TREATMENTS SINCE THEN. THE REPORTED DRAIN VOLUME OF 4900ML WAS 196% OVER THE EXPECTED DRAIN VOLUME WHICH RESULTED IN A REPORTABLE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314848 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization LIBERTY TUBING| PD SOLUTION