BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3980059 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01566
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED A PT DEVELOPED PERITONITIS. THE PT DEVELOPED PERITONITIS AND WAS DIAGNOSED AT THE ER ON (B)(6) 2014. PT WAS TREATED INITIALLY AT THE ER AND WITH FURTHER ANTIBIOTICS AT HER TREATMENT CLINIC. THE LAST DOSE OF ANTIBIOTICS PT RECEIVED WAS ON (B)(6) 2014. PT HAS FINISHED ANTIBIOTICS AND IS CURRENTLY IN GOOD HEALTH; REPEAT CELL COUNT TEST WAS JUST RECENTLY COMPLETED IN THE CLINIC. PDR NURSE STATED PT TESTED FOR (B)(6) AND WAS NOT WEARING A MASK DURING THERAPY; FAILED TO PRACTICE ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370963 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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