BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GESCO

    MDR report key: 2842693 · Received October 6, 2012

    Report

    Report Number
    2842693
    Event Type
    Malfunction
    Date Received
    October 6, 2012
    Date of Event
    September 6, 2012
    Report Date
    October 6, 2012
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FKO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GESCO DIALYSIS SYSTEM LEAKING AT THE STOPCOCK TOWARDS THE DRAIN LINE. MD NOTIFIED. PERITONEAL DIALYSIS CULTURES DRAWN, ANTIBIOTICS INITIATED, AND A NEW GESCO SYSTEM HUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GESCO PERITONEAL DIALYSIS SET, NEONATAL FKO UTAH MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY DIALYSIS