BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3940326 · Received June 19, 2014

    Report

    Report Number
    2937457-2014-01099
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 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

    BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DEPARTMENT HAS REQUESTED MEDICAL RECORDS AND INVESTIGATIONS ARE PENDING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN MEDICAL RECORDS ARE RECEIVED. THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT WAS DIAGNOSED WITH PERITONITIS DURING A PERITONEAL DIALYSIS CLINIC VISIT ON (B)(6) 2014. THE REPORTING NURSE STATED THAT THE EPISODE OF PERITONITIS WAS DUE TO TOUCH CONTAMINATION, WHERE THE PT DID NOT PRACTICE ASEPTIC TECHNIQUE DURING TREATMENT: THE PT DID NOT WASH THEIR HANDS, DID NOT DON A MASK, AND HAD PETS IN THEIR TREATMENT AREA. NO PERITONEAL DIALYSIS TREATMENTS WERE MISSED AND THERE WAS NO REPORTABLE DEVICE MALFUNCTION. AS OF (B)(6) 2014, THE PT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES, THE PT'S SIGNS AND SYMPTOMS OF PERITONITIS HAVE RESOLVED, AND THE PT'S COMPLAINT OF ABDOMINAL PAIN AND VOMITING HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360266 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other DELFLEX PD SOLUTION| LIBERTY CYCLER CASSETTE