BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GESCO

    MDR report key: 2771539 · Received September 4, 2012

    Report

    Report Number
    2771539
    Event Type
    Malfunction
    Date Received
    September 4, 2012
    Date of Event
    August 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GESCO SYSTEM LEAKING AT DARK BLUE STOPCOCK THAT CONNECTS TO THE FILL LINE. CULTURES COLLECTED AND NEW GESCO SYSTEM INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GESCO SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UTAH MEDICAL PRODUCTS * 1121023

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO