BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET

    MDR report key: 7289146 · Received February 22, 2018

    Report

    Report Number
    8030665-2018-00287
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    February 2, 2018
    Report Date
    March 19, 2018
    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
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 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 NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO THE DHR REVIEW CHECKLIST AND RELEASE PROCEDURE. A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS PATIENT REQUESTED ASSISTANCE IN BYPASSING. THE PATIENT STATED WHEN SHE LEANED OVER TO REMOVE HER COMPRESSION SOCK, HER PATIENT LINE CAME UNDONE, DUE TO NOT BEING TIGHTENED ENOUGH. THE PATIENT NOTICED FLUID COMING OUT OF HER CATHETER BUT RECONNECTED RIGHT AWAY. THE PATIENT FELT EMPTY. THE PATIENT WAS ADVISED TO SET UP WITH NEW SUPPLIES AND TO INFORM HER NURSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REQUESTED ASSISTANCE IN BYPASSING. THE PATIENT STATED WHEN SHE LEANED OVER TO REMOVE HER COMPRESSION SOCK, HER PATIENT LINE CAME UNDONE, DUE TO NOT BEING TIGHTENED ENOUGH. THE PATIENT NOTICED FLUID COMING OUT OF HER CATHETER BUT RECONNECTED RIGHT AWAY. THE PATIENT FELT EMPTY. THE PATIENT WAS ADVISED TO SET UP WITH NEW SUPPLIES AND TO INFORM HER PDRN OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134078 LIBERTY CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL 17NR08041 00840861100750

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER| PD FLUID