BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3936045 · Received June 23, 2014

    Report

    Report Number
    2937457-2014-01200
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2014 A PATIENT STATED EXPERIENCED ABDOMINAL PAIN AND SWEATING. PER THE PATIENT'S PERITONEAL DIALYSIS (PD) NURSE, THE PATIENT WAS ENCOURAGED TO GO TO THE CLINIC THE NEXT DAY. THE PATIENT'S (PD) NURSE STATED THAT THERE WAS AFFLUENT DRAINAGE DURING MANUALS AND LABS WERE DRAWN. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014. THE PATIENT'S LAB RESULTS WERE NEGATIVE FOR ANY GROWTH HOWEVER, HE RECEIVED INTRAVENOUS VANCOMYCIN. A FOLLOW-UP CALL TO THE (PD) NURSE WAS MADE, AND IT WAS INDICATED THAT THE PATIENT HAS RECENTLY HAD A SHIFT IN METAL ACTIVITY. THE (PD) NURSE STATED THAT TOUCH CONTAMINATION WAS LIKELY. THE (PD) NURSE ALSO STATED THAT DURING HIS HOSPITALIZATION, POSITIONING OF HIS CATHETER WAS AN ISSUE AND MAY HAVE CONTRIBUTED TO HIS PAIN AND DISCOMFORT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367128 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R DELFLEX PD SOLUTIONS| LIBERTY CYCLER CASSETTE