BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN. EXT. DL

    MDR report key: 3962577 · Received June 30, 2014

    Report

    Report Number
    8030665-2014-00528
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED; HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMITIES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. MEDICAL RECORDS HAVE BEEN REQUESTED AND HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. CYCLER WAS ALARMING AND PATIENT FOUND THAT FLUID HAD SPILLED ALL OVER THE FLOOR. PATIENT STATED THAT HE WAS PLACED ON ANTIBIOTICS FOR THE NEXT TWO WEEKS. HE ALSO STATED THAT HE HAS A LOT OF STOMACH PAIN AND DISCOMFORT. PATIENT CONFIRMED THAT NURSE IS AWARE OF HIS PAIN. NURSE STATED THAT PATIENT WENT TO ER ON (B)(6)2014 FOR SEVERE ABDOMINAL PAIN AND WAS TREATED WITH VANCOMYCIN; ANTIBIOTICS FOR EVERY OTHER FOUR DAYS. PATIENT WAS NOT ADMITTED AND LEFT THE ER THAT DAY (B)(6) 2014. PDRN IS NOT SURE WHAT CAUSED THE PAIN. THERE WAS NO BACTERIA, PATIENT'S EFFLUENT REMAINED CLEAR AND HAD NO PERITONITIS. A COMPLAINT HISTORY OF THE PATIENT DETERMINED THAT NO LEAKS HAVE OCCURRED SINCE THIS REPORTED EVENT THAT OCCURRED ON (B)(6) 2014 AND BEFORE PATIENT WENT TO THE ER. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378628 LIBERTY CYCLER SET, SINGLE CONN. EXT. DL FKX FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING 13PR08046

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR LIBERTY DIALYSIS CYCLER, PD SOLUTION