BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERY CYCLER SET, SINGLE CONN/EXT DL

    MDR report key: 4180389 · Received October 15, 2014

    Report

    Report Number
    8030665-2014-00800
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 14, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION, AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER OVER THE PAST 3 MONTHS. BATCH RECORDS FOR THE LOST IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE USER ACKNOWLEDGED NOT TIGHTENING THE CONNECTION ENOUGH AND RETIGHTENING RESOLVED THE LEAK.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT'S CONTACT REPORTED THAT HE FOUND A FLUID LEAK DURING FILL 1 BETWEEN HIS CATHETER EXTENSION AND HIS CYCLER SET. HE WAS ABLE TO TIGHTEN THE CONNECTION AND THE LEAK STOPPED. HE COMPLETED TREATMENT. THE SET WAS DISCARDED. DURING FOLLOW UP, THE PT'S PD NURSE REPORTED THAT THE PT DID NOT HAVE ANY SIGNS OF INFECTION. HIS EFFLUENT WAS CLEAR. HE WAS NOT PRESCRIBED ANY ANTIBIOTICS. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655303 LIBERY CYCLER SET, SINGLE CONN/EXT DL FKX FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR STAY SAFE/LUER LOCK CATHETER EXT 12 INC| PD FLUID| LIBERTY CYCLER