BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY DRAIN LINE, LUER TAPER CONNECTOR

    MDR report key: 4040474 · Received August 15, 2014

    Report

    Report Number
    8030665-2014-00637
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    September 1, 2013
    Report Date
    July 17, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE, REYNOSA MANUFACTURING
    Product Code
    KDJ
    PMA / PMN Number
    K915628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERIOUS INJURY HAS OCCURRED TO A PERITONEAL DIALYSIS PATIENT FOLLOWING TREATMENT WITH A FRESENIUS PRODUCT. DUE TO LACK OF INFORMATION AN MDR WILL BE FILED AGAINST THE PRODUCT WHILE UNDERGOING REVIEW BY THE POST MARKET CLINICAL DEPARTMENT AND MANUFACTURING PLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LETTER TO THE EDITOR IN THE (B)(6) 2013 - VOL. 33 NO. 5 EDITION OF PERITONEAL DIALYSIS INTERNATIONAL, "INCREASE IN PERITONITIS RATES WITH THE REUSE OF DRAIN TUBING OF THE FRESENIUS LIBERTY CYCLER" THAT (B)(6) INCIDENTS OF PERITONITIS OCCURRED ACROSS 9 PATIENTS. THE STUDY WAS ACROSS ALL PATIENT AT THE CLINIC FROM (B)(6) 2008 THROUGH (B)(6) 2012, HOWEVER THE DRAIN LINE REUSE INCIDENTS WERE REPORTED FROM (B)(6) 2008 THROUGH (B)(6) 2011. WITHIN THAT TIME PERIOD EIGHT PATIENTS HAD REPORTED TREATMENT WITH A LIBERTY CYCLER AND THEY HAD AT LEAST A SINGLE EVENT OF PERITONITIS. NO INFORMATION IS AVAILABLE TO DIFFERENTIATE THE PATIENTS OR HOW MANY INFORMATION IS AVAILABLE TO DIFFERENTIATE THE PATIENTS OR HOW MANY OCCURRENCES OF PERITONITIS WERE REPORTED FOR EACH PATIENT. ONE PATIENT WAS NOT USING A FRESENIUS LIBERTY CYCLER BUT HAD TWO INCIDENTS OF PERITONITIS; ONE WITH NO GROWTH IN CULTURE THE OTHER ATTRIBUTED TO TOUCH CONTAMINATION. THE OCCURRENCES OF PERITONITIS WERE INVESTIGATED TO CAUSE AND ASSOCIATION WITH PATIENT DEMOGRAPHICS BUT THE SPECIFICS OF WHICH ARE NOT AVAILABLE. THE AUTHOR ATTRIBUTES 19 CASES WHERE THE REUSE OF THE DRAIN LINE COULD NOT BE RULED OUT AS CONTRIBUTORY. THE CLINIC INSTRUCTED USERS TO CHANGE THEIR DRAIN LINES WEEKLY. NOTE THAT THE AUTHOR ACKNOWLEDGES THAT THE MANUFACTURER'S INSTRUCTIONS RECOMMEND CHANGING THE DRAIN LINE EVERY DAY. IN (B)(6)2011 THE CLINIC BEGAN INSTRUCTING USERS TO CHANGE THE DRAIN LINE EVERY DAY AND THE RATE OF PERITONITIS CASES DECREASED. NO PATIENT OUTCOMES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490660 LIBERTY DRAIN LINE, LUER TAPER CONNECTOR KDJ FRESENIUS MEDICAL CARE, REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER