BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 3210826 · Received July 2, 2013

    Report

    Report Number
    2937457-2013-00088
    Event Type
    Other
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INFORMATION AVAILABLE WAS PERFORMED BY THE POST MARKET CLINICAL DEPARTMENT AS PROVIDED BY THE PATIENT. A LARGE INTRA-PERITONEAL VOLUME DRAINED MANUALLY FOLLOWING THE PATIENT'S PRESCRIBED CCPD TREATMENT OCCURRED WITH AN UNDETERMINED CAUSE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED LARGE DRAIN VOLUME. THE PERITONEAL CYCLER (PLANT INVESTIGATION) IS CURRENTLY UNDERGOING EVALUATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT CALLED TECH SUPPORT AND STATED THAT THE MACHINE HAS BEEN MAKING A HUMMING SOUND DURING TREATMENT. HE ALSO STATED THAT HE HAS BEEN HAVING DRAIN ISSUES FOR THE PAST FEW DAYS. ADDITIONALLY, HE FEELS THAT THE CYCLER IS NOT DRAINING ENOUGH FLUID BECAUSE HE HAD TO COMPLETE A MANUAL DRAIN FOLLOWING THE TREATMENT AND DRAINED 4200ML DUE TO THE FEELING OF ABDOMINAL DISCOMFORT/PAIN. HE PROVIDED THE FOLLOWING TREATMENT DATA: SEE SCANNED PAGE. MANUAL DRAIN 4200ML. THE REPORTED LARGE POST TREATMENT MANUAL DRAIN OF 4200ML EXCEEDS THE 180% DRAIN CRITERIA OF THE PRESCRIBED FILL VOLUME OF 1600ML FOR A REPORTABLE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302398 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER SET| DELFLEX SOLUTION