BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4346229 · Received December 18, 2014

    Report

    Report Number
    2937457-2014-03435
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    July 31, 2012
    Report Date
    August 30, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CYCLER WAS REPLACED FOR THE REPORTED ISSUES M31 AIR DETECTED IN CASSETTE WARNING AND DRAIN VOLUME (DV) UP TO 180% OF PRESCRIBED FV. CYCLER IS NOT AVAILABLE FOR INVESTIGATION DUE TO CONFIRMED INFESTATION. FAILURE ANALYSIS COULD NOT BE PERFORMED. THE PATIENT'S MEDICAL RECORDS WERE RECEIVED AND A CLINICAL INVESTIGATION WAS PERFORMED: AIR IN THE ABDOMINAL CAVITY MAY RESULT IN PAIN OR DISCOMFORT BUT IS NOT LIKELY TO RESULT IN SERIOUS INJURY. CERTAIN DIAGNOSTIC PROCEDURES EVEN REQUIRE THE INTRODUCTION OF LARGE AMOUNTS OF GAS/AIR. THE RESIDUAL GAS/AIR MAY RESULT IN SHOULDER PAIN OR DISCOMFORT BUT NO MEDICAL INTERVENTION IS NECESSARY. THE AIR DISSIPATES IN A FEW DAYS. THERE IS NO CONTACT BETWEEN DIALYSIS SOLUTION AND CYCLER WHICH WOULD CAUSE AN INFECTION. THERE WAS NO REPORT OF A FLUID LEAK. MOST COMMON CAUSE OF PERITONITIS IS TOUCH CONTAMINATION.

    Description of Event or Problem · 1

    DURING A CALL TO TECHNICAL SUPPORT, THE PERITONEAL DIALYSIS (PD) PATIENT'S WIFE REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR A PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831609 FRESENIUS LIBERTY CYCLER FKX FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention