BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS LIBERTY CYCLER

    MDR report key: 4112613 · Received September 10, 2014

    Report

    Report Number
    2937457-2014-02683
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    March 14, 2012
    Report Date
    March 14, 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. A VISUAL INSPECTION SHOWED NO PHYSICAL EXTERIOR DISCREPANCIES. AFTER REPAIR OF A BALLOON VALVE, ALL FUNCTIONAL TESTS PASSED. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITH NO ISSUES OR ALARMS. THE REPORTED SYMPTOMS WERE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THERE WERE NO UNEXPLAINED 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, THE EVENT OF PERITONITIS IS UNLIKELY RELATED TO THE LIBERTY CYCLER MACHINE, PERITONITIS IN A PT UNDERGOING PERITONEAL DIALYSIS IS MOST OFTEN DUE TO CONTAMINATION WITH PATHOGENIC SKIN BACTERIA RESULTING FROM TOUCH CONTAMINATION. THE PT WAS TREATED FOR PERITONITIS AND CONTINUES ON CONTINUOUS CYCLE PERITONEAL DIALYSIS. 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 (B)(6) 2011 TO (B)(6) 2013.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT CALLED FRESENIUS TECH SUPPORT STATING HE WAS IN SETUP WHEN HE GOT THE M71.2 ALARM AND THE PT STATED HE JUST GOT HOME FROM THE HOSP. TECH SUPPORT ASKED IF THIS WAS CYCLER RELATED AND HE STATED YES HE GOT PERITONITIS AND WAS IN THE HOSP FOR 4 DAYS. TECH SUPPORT REPLACED THE CYCLER AND ADVISED TO DISCONTINUE USE OF THE CYCLER AND F/U WITH CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559794 FRESENIUS LIBERTY CYCLER PERITONEAL DIALYSIS SYSTEM FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R