BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4072060 · Received August 29, 2014

    Report

    Report Number
    2937457-2014-02451
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    March 13, 2012
    Report Date
    March 13, 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

    THE LIBERTY CYCLER WAS RETURNED FOR EVALUATION; NO NON-CONFORMITIES WERE FOUND. THE UNIT PASSED ALL TESTS DURING SIMULATED TREATMENT TESTING AND MET SPECIFICATIONS. THERE WAS NO INDICATION OF AN EQUIPMENT FAILURE. A BATCH RECORD REVIEW WAS CONDUCTED AND CONFIRMED THERE WERE NO DEVIATIONS OR NON-CONFORMANCES. PRODUCT LABELING, MATERIAL, AND PROCESS CONTROLS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE CLINICAL INVESTIGATION INDICATES, AS PER THE PERITONEAL DIALYSIS RN, THE PATIENT WOULD DISCONNECT HIMSELF FROM THE CYCLER AND GO TO THE BATHROOM WHILE HOLDING THE OPEN (END) OF HIS PD CATHETER, DO CCPD EXCHANGES WITH OTHER PEOPLE IN THE SAME ROOM, AND WASHED HANDS FOR 15 SECONDS INSTEAD OF 1-2 MINUTES. THE PD CATHETER WAS REMOVED DUE TO BIOFILM AND A NEW PD CATHETER WAS SCHEDULED FOR INSERTION. THERE WAS NO CONTACT BETWEEN DIALYSIS SOLUTION AND THE CYCLER WHICH WOULD CAUSE AN INFECTION THERE WAS NO REPORT OF A FLUID LEAK DURING CCPD TREATMENT. THE PATIENT'S IMPROPER TECHNIQUE DURING CCPD TREATMENT PLACED THE PATIENT AT HIGH RISK FOR INFECTION. THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MEDICAL CARE AS A REMEDIATION ACTION COMMITTED TO FDA REGARDING ALL POTENTIAL ADVERSE EVENTS RECEIVED BETWEEN 21 MARCH 2011 TO 11 MARCH 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT'S WIFE, THE PATIENT/USER OF THE FMC DEVICE WAS NOT FEELING WELL AND HIS DRAIN BAGS WERE CLOUDY. THE PATIENT HAD AN INITIAL OF PERITONITIS IN (B)(6) 2012 AND A RECURRENCE OF PERITONITIS IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527872 FRESENIUS LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LIBERTY CYCLER TUBING SET AND PD SOLUTIONS