BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET SINGLE CONN. / EXT. DL.

    MDR report key: 3821812 · Received May 9, 2014

    Report

    Report Number
    8030665-2014-00364
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    July 12, 2012
    Report Date
    August 6, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS UNABLE TO CONTACT THE INITIAL REPORTER AS PATIENT INFORMATION WAS WITHHELD FROM THE (B)(4). THIS MDR INCLUDES ALL INFORMATION RECEIVED TO DATE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. NO MEDICAL RECORDS ARE AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF PERFORMING A CLINICAL AND PLANT INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS RELATED TO MDRS # 2937457-2014-00795 AND 8030665-2013-00579.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA (B)(4). A PERITONEAL DIALYSIS PATIENT DEVELOPED A MULTI ORGANISM PERITONITIS. THE PATIENT HAD CLOUDY EFFLUENT WHICH WAS REPORTED TO BE E COLI, CITROBACTER BRAAKII AND (2) ANAEROBES. THE PATIENT WAS ADMINISTERED ANTIBIOTICS FOR ONE MONTH WHILE BEING TREATED AS AN OUTPATIENT. THE PATIENT WAS THEN ADMINISTERED ANTIBIOTICS BY MOUTH AND INTRAPERITONEAL. ON APPROXIMATELY (B)(6) 2012 THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM WITH SEVERE ABDOMINAL PAIN, DIARRHEA, VOMITING AND FEVER. THE PATIENT WAS REPORTED TO BE IN THE HOSPITAL FOR 6 DAYS WITH LIFE THREATENING PERITONITIS. THE PATIENT BEGAN HEMODIALYSIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH ANTIBIOTICS AND CONTINUED HEMODIALYSIS TREATMENT FOR FOUR MONTHS. THE PATIENT REPORTS HAVING LOST FLUID DUE TO THE PERITONITIS CAUSING LOW BLOOD SUGAR DURING TREATMENTS. IT IS REPORTED THAT A LEAK WAS IDENTIFIED IN THE TUBING DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282239 LIBERTY CYCLER SET SINGLE CONN. / EXT. DL. NONE FKX FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R LIBERTY CYCLER| STAY SAFE CATHETER| DELFLEX