BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET SINGLE CONN/EXT

    MDR report key: 2142123 · Received May 26, 2011

    Report

    Report Number
    8030665-2011-00025
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 26, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE HAS REPORTED THAT ON (B)(6), 2011, HER PT WOKE UP AND FOUND THAT HIS BED WAS WET. THE PT STATED THAT HE NOTICED A DRIP AT THE SITE WHERE THE CONNECTOR OF THIS SET CONNECTS TO THE EXTENSION SET. FOR THIS EVENT, THE RN CHANGED THE EXTENSION SET AND SHE REPORTED THAT SHE COULD NOT FIND A DEFECT IN THE USED PRODUCT. SHE PLACED A NEW EXTENSION SET, AND THE PT WAS TREATED WITH ONE DOSE OF PROPHYLACTIC ANTIBIOTICS FOR THE BREAK IN THE SYS. ALSO THE RN OBTAINED A CELL COUNT AND CULTURE OF EFFLUENT. NO CLOUDY BAGS WERE OBSERVED. PT CURRENTLY CONTINUES PERITONEAL DIALYSIS. A SAMPLE IS AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET SINGLE CONN/EXT PERITONEAL DIALYSIS TUBING FKX REYNOSA MANUFACTURING NA 11BR08003

    Patients

    Seq Age Sex Outcome Treatment
    1 NI