BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 3874923 · Received June 2, 2014

    Report

    Report Number
    8030665-2014-00455
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    March 29, 2014
    Report Date
    May 2, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WA CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. A CLINICAL INVESTIGATION WS PERFORMED BY THE POST MARKET CLINICAL STAFF. IT FINDS THE FOLLOWING: THIS IS A PATIENT WITH HISTORY OF ESRD ON HOME PERITONEAL DIALYSIS; REPORTEDLY, PATIENT SUFFERED AN EVENT OF PERITONITIS. PERITONITIS IS A KNOWN COMPLICATION OF PERITONEAL DIALYSIS, CAUSED BY POOR ASEPTIC TECHNIQUE OR A BREAK IN THE STERILE FILED. THIS EVENT OF PERITONITIS MAY HAVE RESULTED FROM USE ERROR.

    Description of Event or Problem · 1

    A PATIENT CALLED INTO TECHNICAL SUPPORT FOR AN UNRELATED ISSUE AND REPORTED HE HA BEEN TREATED FOR PERITONITIS. FOLLOW UP WITH PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONFIRMED THE PERITONITIS DIAGNOSIS. ACCORDING TO THE MEDICAL RECORDS RECEIVED, THE PATIENT PRESENTED TO EMERGENCY ROOM ON (B)(6) 2014 WITH COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, AND VOMITING. HE HAD A LOW GRADE FEVER OF 99.1. THE PATIENT REPORTED "A COUPLE DAYS AGO THE DRAINPIPE FELL INTO THE TOILET" DURING HIS CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) TREATMENT. HE THEN CLEANED IT OFF AND CONTINUED USING IT. HE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 AND TREATED WITH ANTIBIOTICS. HE WAS DISCHARGED TO HOME ON (B)(6) 2014. HE IS CONTINUING ON CCPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321181 LIBERTY CYCLER SET, SINGLE CONN./EXT.DL FKX FRESENIUS MEDICAL CARE NORTH AMERICA 13PR08087

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R LIBERTY CYCLER CASSETTE| LIBERTY CYCLER| FRESENIUS PERITONEAL DIALYSIS SOLUTION