BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3911959 · Received May 13, 2014

    Report

    Report Number
    8030665-2014-00367
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED FINDING A FLUID LEAK FOLLOWING HIS TREATMENT. WHEN HE OPENED THE CASSETTE DOOR THERE WAS FLUID PRESENT. THE PT ALSO REPORTED DISCOMFORT AND BRIEF PAIN DURING SOME PARTS OF THE TREATMENT CYCLE. HE WAS ADVISED TO DISCONTINUE USING THE CYCLER AND FOLLOW UP WITH HIS PD NURSE. HE DISCARDED THE SET. DURING FOLLOW UP THE PT'S NURSE REPORTED THAT HIS EFFLUENT HAS REMAINED CLEAR. HE WAS TREATED WITH PROPHYLACTIC ANTIBIOTIC, ONE DOSE VANCOMYCIN. HE DID NOT HAVE ANY SIGNS OF INFECTION. THE NURSE REPORTED THE PAIN HE WAS EXPERIENCING DURING TREATMENT WAS DUE TO PD CATHETER PLACEMENT ISSUE AND HIS PHYSIOLOGY. HE WAS ADVISED TO FOLLOW UP WITH THE PD CATHETER PHYSICIAN. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285392 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING 13PR08056

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR LIBERTY CYCLER