BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 6588363 · Received May 24, 2017

    Report

    Report Number
    8030665-2017-00265
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    April 29, 2017
    Report Date
    June 28, 2017
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100750
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. 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.

    Additional Manufacturer Narrative · 1

    EVENT DATE IS (B)(6).

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW IS IN PROGRESS. A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED UPON RECIEPT OF ADDITIONAL INFORMAITION

    Description of Event or Problem · 1

    UPON COMPLETION OF HIS TREATMENT, A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED FLUID LEAKING FROM HIS PD CYCLER'S DISPOSABLE CASSETTE. THE PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE STATED THAT THE PATIENT EXPERIENCED NO ADVERSE EVENT RELATED TO THE FLUID LEAK. THE PATIENT WAS ASYMPTOMATIC, WAS NOT ADMINISTERED AN ANTIBIOTIC, AND WAS NOT HOSPITALIZED. THE SET WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370139 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 16SR08012 00840861100750

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PD SOLUTIONS