BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERY CYCLER

    MDR report key: 4110830 · Received September 10, 2014

    Report

    Report Number
    2937457-2014-02693
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT CALLED IN WITH DRAIN COMPLICATIONS DURING HER PERITONEAL DIALYSIS TREATMENT. THE PATIENT'S HUSBAND REPORTED A "BROWN COTTON LIKE" SUBSTANCE IN THE TOILET WHERE THE PATIENT DRAINS. A FOLLOW UP CALL WAS MADE TO THE PATIENT'S PERITONEAL DIALYSIS NURSE; SHE REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2014 AND WAS NOTED TO HAVE CLOUDY FLUID. THE PATIENT WAS STARTED ON INTRA-PERITONEAL ANTIBIOTICS (VANCOMYCIN 1G) EVERY FIVE DAYS FOR 21 DAYS. THE NURSE REPORTED THAT THIS WAS THE PATIENT'S SECOND CASE OF "TOUCH" CONTAMINATION PERITONITIS IN THE LAST SIX MONTHS (PREVIOUSLY REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559783 LIBERY CYCLER FKX FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LIBERTY TUBING, PD SOLUTION