BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3853020 · Received May 23, 2014

    Report

    Report Number
    8030665-2014-00442
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    November 28, 2011
    Report Date
    April 24, 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

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. MEDICAL RECORDS WERE PROVIDED AND HAVE BEEN REVIEWED BY POST MARKET CLINICAL STAFF AND PHYSICIAN. PT WITH END STAGE RENAL DISEASE ON HOME PERITONEAL DIALYSIS (PD) USING THE LIBERTY CYCLER; REPORTEDLY, PT SUFFERED AN EVENT OF PERITONITIS, UNCOMPLICATED AND TREATED AS AN OUTPATIENT. PERITONITIS IS A KNOWN COMPLICATION OF PD CAUSED BY POOR ASEPTIC TECHNIQUE OR A BREAK IN THE STERILE FILED. THIS EVENT OF PERITONITIS MAY HAVE RESULTED FROM USE ERROR. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION. THIS MEDWATCH IS RELATED TO MDRS# 2937457-2014-00877 AND 8030665-2014-00442.

    Description of Event or Problem · 1

    THROUGH THE REVIEW OF MEDICAL RECORDS RECEIVED ON (B)(4) 2014 FOR AN UNRELATED EVENT, IT WAS REPORTED THAT THE PT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2011. FINDINGS FROM THE MEDICAL RECORDS: ON (B)(6) 2011, THE PT WAS SEEN IN THE PERITONEAL DIALYSIS (PD) CLINIC WITH COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, AND DIARRHEA. ON (B)(6) 2011, HE CALLED THE PDRN AND WAS INSTRUCTED TO GIVEN HIMSELF VANCOMYCIN 2GMS AND CEFTAZIDIME 1GM AT HOME INTRAPERITONEAL (IP). HE SAVED HIS CLOUDY BAG FOR A CELL COUNT AND CULTURE. HE STATED HE WAS FEELING A LITTLE BETTER, BUT STILL HAD SOME DIARRHEA. HIS PD DRAIN FLUID WAS YELLOW BUT CLEAR. HE WAS INSTRUCTED TO RETURN TO THE CLINIC NEXT DAY FOR IPCEFTAZIDIME. THERE WERE NO LAB OR CULTURE RESULTS IN THE PT'S MEDICAL RECORDS. THE PT WAS DIAGNOSED WITH PERITONITIS, ORGANISM UNK, DUE TO GROSS CONTAMINATION OF HIS PD SYSTEM. THE PT HAS A HISTORY OF NON-COMPLIANCE WITH ASEPTIC TECHNIQUE DURING HIS PD TREATMENTS. THIS IS THE PT'S THIRD EPISODE OF PERITONITIS IN 2011. ON (B)(6) 2011, THE PT WAS SEEN IN THE PD CLINIC DUE TO FORGETTING TO CLAMP THE MACHINE AND UNUSED CONNECTION LINE AND THE SYSTEM WAS OPEN ALL NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309111 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE NORTH AMERICA 11HR08058

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R LIBERTY CYCLER| DELFLEX