BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4202469 · Received October 22, 2014

    Report

    Report Number
    2937457-2014-03028
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    May 8, 2013
    Report Date
    September 22, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    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 CLINICAL DEPARTMENT IS THE PROCESS OF REQUESTING PT MEDICAL RECORDS AND TREATMENT DATA INFO REGARDING THE REPORTED HOSPITALIZATION FOR PERITONITIS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A FAX WAS RECEIVED FROM THE CLINICAL MANAGER OF A CHRONIC OUT-PATIENT DIALYSIS FACILITY FOR FOLLOW UP OF AN UNRELATED EVENT. INFO PROVIDED ALLEGED THREE HOSPITALIZATION FOR PERITONITIS. FOLLOW UP WITH THE CLINICAL MANAGER FOR THESE EVENTS CONFIRMED THE HOSPITALIZATIONS. CAUSE OF THE PERITONITIS IS BREACH IN ASEPTIC TECHNIQUE. THE PERITONEAL DIALYSIS CATHETER WAS REMOVED ON (B)(6) 2013 AND THE PT WAS CHANGED TO HEMODIALYSIS PERMANENTLY. THE PT EXPIRED FROM UNRELATED CAUSE ON (B)(6) 2013. NO OTHER INFO IS AVAILABLE. A SEARCH OF THE COMPLAINT INFO SYSTEM CONFIRMED THERE WERE NO PRODUCT COMPLAINTS OF LEAKS DURING TREATMENT WHICH COULD HAVE CONTRIBUTED TO THE PERITONITIS DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671979 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LIBERTY CYCLER SET| FRESENIUS PD SOLUTION