BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE PATIENT CONN

    MDR report key: 2860454 · Received December 5, 2012

    Report

    Report Number
    8030665-2012-00375
    Event Type
    Injury
    Date Received
    December 5, 2012
    Report Date
    November 8, 2012
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER AND INFORMATION IS PROVIDED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT ALLEGED THAT A CASSETTE FLUID LEAK OCCURRED BEFORE THE DIAGNOSIS OF PERITONITIS. HE STATES THAT AFTER TREATMENT, WHEN HE WAS REMOVING THE CASSETTE FROM THE CYCLER HE NOTICED FLUID ON THE DOMES INSIDE THE CYCLER. NO SAMPLE IS AVAILABLE. THE PATIENT DEVELOPED NEW ONSET OF PERIUMBILICAL AND EPIGASTRIC ABDOMINAL PAIN. A FEW DAYS LATER, ON (B)(6) 2012, THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND WAS ADMITTED WITH A DIAGNOSIS OF RULE OUT PERITONITIS. AT THE TIME OF ADMISSION, PD EFFLUENT LABS WERE DRAWN WHICH SHOWED CLOUDY EFFLUENT. PATIENT WAS STARTED ON INTRAPERITONEAL (IP) ANTIBIOTICS OF CEFTAZIDIME AND CEFAZOLIN. ON (B)(6) 2012, PATIENT WAS DISCHARGED TO HOME WITH DIAGNOSIS OF PERITONITIS. THE FINAL CULTURE RESULTS SHOWED NO GROWTH. PATIENT CONTINUED ON IP ANTIBIOTICS FOR 21 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE PATIENT CONN LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O LIBERTY DIALYSIS CYCLER