BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE PATIENT CON

    MDR report key: 4961976 · Received July 31, 2015

    Report

    Report Number
    8030665-2015-00342
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 12, 2015
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    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 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 THREE MONTHS. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT REPORTED FINDING A FLUID LEAK. THE PT'S CONTACT STATED THAT AFTER RECEIVING A "FILL COMPLICATION" CYCLER WARNING, THE PT NOTICED FLUID LEAKING FROM THE CONNECTION BETWEEN THE SOLUTION BAGS AND THE CYCLER TUBING SET. THE PT CONTACT WAS ADVISED TO CONTACT THE PT'S PD NURSE. THE SET WAS NOT MADE AVAILABLE FOR EVALUATION. DURING FOLLOW UP, THE PT'S PD NURSE STATED THE PT DID NOT HAVE ANY SIGNS OF INFECTION AND HAS NOT BEEN GIVEN ANY ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499224 LIBERTY CYCLER SET, SINGLE PATIENT CON FKX ERIKA DE REYNOSA, S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR