BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN. EXT. DL

    MDR report key: 3911954 · Received May 13, 2014

    Report

    Report Number
    8030665-2014-00371
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 15, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PT HAD A LEAK IN HER CYCLER SET NEAR THE PIN. THE PT WAS CHECKED IN CLINIC AND HAD CLEAR EFFLUENT AND NO SIGNS OF INFECTION. SHE WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS ANCEF AND CEFTAZIDIME. THE NURSE HAS THE SET AND IS RETURNING IT FOR EVAL. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285287 LIBERTY CYCLER SET, SINGLE CONN. EXT. DL FKX REYNOSA MANUFACTURING 13PR08808

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR LIBERTY CYCLER