BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS (ECO PLUS)

    MDR report key: 376045 · Received February 5, 2002

    Report

    Report Number
    376045
    Event Type
    Injury
    Date Received
    February 5, 2002
    Date of Event
    January 21, 2002
    Report Date
    January 22, 2002
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THEY AWOKE FROM PD CYCLER TREATMENT AT 4:00AM TO FIND FLUID LEAKING FROM 2ND PRE-FILLED CONNECTION. PT INSTRUCTED TO DISCONTINUED TREATMENT AND COME TO CLINIC. GIVEN VANCOMYCIN 2GM INTRAPERITONEALLY. PT REPORTED TO CLINIC THE NEXT DAY WITH COMPLAINT OF CLOUDY FLUID, ABDOMINAL PAIN. SPECIMENS SENT FOR CELL COUNT, CULTURE AND SENSITIVITY. PT STARTED ON TOBRAMYCIN IP PER ORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS (ECO PLUS) 4 LEAD CYCLER TUBING PD PLUS KPF FRESENIUS MEDICAL CARE * 1LR807

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention