BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4091398 · Received August 28, 2014

    Report

    Report Number
    2937457-2014-02386
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 31, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERIOUS INJURY HAS OCCURRED TO A PERITONEAL DIALYSIS PATIENT FOLLOWING TREATMENT WITH A CYCLER. DUE TO LACK OF INFORMATION AN MDR WILL BE FILED AGAINST THE CYCLER WHILE UNDERGOING REVIEW BY POST MARKET CLINICAL DEPARTMENT AND MANUFACTURING PLANT.

    Description of Event or Problem · 1

    REPORTED VIA MEDICAL RECORDS FOR A PERITONEAL DIALYSIS (PD) PATIENT. THE PATIENT WAS POSITIVE FOR PERITONITIS DUE TO ENTEROCOCCUS FAECALIS DIAGNOSED VIA PD EFFLUENT CULTURE. THE CULTURE RESULT WAS INCLUDED. DURING FOLLOW UP THE PATIENT'S PD NURSE REPORTED THAT THE PATIENT WAS TREATED WITH VANCOMYCIN FOR 3 WEEKS WITHOUT HOSPITALIZATION. THE EVENT WAS DUE TO SELF CONTAMINATION WITHOUT A REPORTED MALFUNCTION. PATIENT'S STERILE TECHNIQUE WAS REPORTED TO BE POOR AND HE WOULD FORGET TO WASH HIS HANDS OR APPLY A MASK WHEN CONNECTING. THERE WERE NO CYCLER MALFUNCTIONS, LEAKS, OR SUPPLY BAG ISSUES ASSOCIATED WITH THIS EVENT. THE PATIENT CONTINUED PD UNTIL (B)(6) 2014 WHEN HE SWITCHED OVER TO HEMODIALYSIS. THE PATIENT WAS LAST TRANSFERRED OVER TO A SPECIAL CARE HOSPITAL ON (B)(6) 2014 AND CONTINUED HEMODIALYSIS THERE. AS THE PATIENT DISCONTINUED PD HIS CYCLER HAS BEEN RETURNED TO THE MANUFACTURING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523361 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention CIPROFLOXACIN| OMEPRAZOLE| VITAMIN D2| CALCITRIOL| DELFLEX SOLUTION| ASPIRIN| FOLIC ACID| KLOR-CON| MAGNESIUM OXIDE| METOPROLOL SUCCINATE| TACROLIMUS| VITAMIN C| ZINC SULFATE| DUAL PATIENT CONNECT| AZATHIOPRINE| HYDROCODE-ACETOMINOPHEN| CITALOPRAM| LIBERTY CYCLER SET| LEVOTHYROXINE| EPOGEN