BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERT CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3853018 · Received May 23, 2014

    Report

    Report Number
    8030665-2014-00443
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    September 29, 2011
    Report Date
    April 24, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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# 2937457-2014-00878 AND 8030665-2014-00443.

    Description of Event or Problem · 1

    THROUGH THE REVIEW OF MEDICAL RECORDS RECEIVED ON (B)(6) 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 AND HIS WIFE WENT TO THE PERITONEAL DIALYSIS (PD) CLINIC IN ORDER TO MEET WITH THE INTERDISCIPLINARY TEAM. THE PT'S WIFE BROUGHT IN A CLOUDY DRAIN BAG WITH FIBRIN PRESENT. A CULTURE, CELL COUNT, AND GAMASTAN WERE ORDERED. THE PT RECEIVED ANCEF 1GM AND FORATZ 1GM INTRAPERITONEAL. DURING THE VISIT, THE PT'S WIFE WAS EXTREMELY UPSET OVER THE FACT THE PT DOES NOT TAKE CARE OF HIMSELF. THERE WERE NO RESULTS FOR THIS EVENT OF PERITONITIS IN THE PT'S RECORD. ON (B)(6) 2011, THE PT CAME INTO THE PD CLINIC TO RECEIVE ANTIBIOTICS. THE RESULT OF HIS PD CULTURE SHOWED (B)(6). HIS ANTIBIOTIC WAS SWITCHED TO VANCOMYCIN IP. HE DENIED ANY SYMPTOMS OF PERITONITIS. THE PDRN REVIEWED POSSIBLE CAUSES OF PD CONTAMINATION WITH THE PT. THIS IS THE SECOND EPISODE OF PERITONITIS IN 2011. A HOME VISIT FROM THE PDRN AND PD RETRAINING WAS SCHEDULED FOR (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309124 LIBERT CYCLER SET, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE NORTH AMERICA 11DR08080

    Patients

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