BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3862805 · Received May 28, 2014

    Report

    Report Number
    2937457-2014-00895
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 28, 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 REPORTED THAT HE WAS ON ANTIBIOTICS. A FOLLOW UP CALL WAS MADE TO THE PATIENT'S PERITONEAL DIALYSIS NURSE. THE NURSE REPORTED THAT THE PATIENT WAS STARTED ON VANCOMYCIN AND GENTAMYCIN ON (B)(6) 2014 FOR PERITONITIS. THE NURSE REPORTED THIS AS TOUCH CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314850 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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