BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4083463 · Received August 19, 2014

    Report

    Report Number
    2937457-2014-02193
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    November 11, 2012
    Report Date
    November 11, 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

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE EXTERIOR OF THE DEVICE SHOWS NO PHYSICAL DAMAGE. THERE WAS NO EVIDENCE OF DRIED FLUID INSIDE OF THE CASSETTE COMPARTMENT. A SIMULATED TREATMENT WAS COMPLETED WITHOUT ALARMS OR FAILURES. THE REPORTED PROBLEMS WERE NOT CONFIRMED. A REVIEW WAS PERFORMED FOR THE DEVICE HISTORY RECORD. THERE WERE NO UNEXPECTED VARIANCES, ADJUSTMENTS OR COMMENTS NOTED IN THE DEVICE RECORDS. A REVIEW OF THE COMPLAINT TRACKING SYSTEM LISTED NO OTHER COMPLAINTS FOR THE REPORTED SYMPTOMS FOR THIS DEVICE. A REVIEW WAS PERFORMED BY THE POST MARKET CLINICAL DEPT. PER THE PHARMACOVIGILANCE PHYSICIAN, PERITONEAL IS A KNOWN COMPLICATION OF PERITONEAL DIALYSIS,M CAUSED BY A BREAK IN THE STERILE FIELD AND/OR ASEPTIC TECHNIQUE. THERE IS NO CONFIRMED HISTORY OF DEVICE MALFUNCTION OR CASSETTE LEAK WHICH COULD HAVE CONTRIBUTED TO THIS EVENT OF PERITONITIS. THE BACTERIA IDENTIFIED ARE COMMON SKIN FLORA. 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 03/21/2011 TO 03/11/2013.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT CALLED FRESENIUS TECH SUPPORT WHILE IN DWELL 2 OF 4 WITH SUPPLY BAG LINES ARE BLOCKED ALARMS. THE PT WAS UNABLE TO PROVIDE CATALOG OR LOT NUMBER FOR THE TUBING SET. TECH SUPPORT INFORMED THE PT IN REGARDS TO THE ALARM. THE PT CHECKED FOR KINKS, COILS, CLAMPS AND STATED ALL WAS OK. THE PT ALSO MENTIONED IN THE PREVIOUS TREATMENT END THE TUBING SET LEAKED ON THE CYCLER. TECH SUPPORT INFORMED THE PT IN REGARDS TO THE FLUID LEAK. THE CYCLER IS BEING REPLACED. THE PT WILL CONTACT HIS PERITONEAL DIALYSIS NURSE REGARDING ALTERNATE TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496955 FRESENIUS LIBERTY CYCLER PERITONEAL DIALYSIS SYSTEM FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other