BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET

    MDR report key: 6852890 · Received September 8, 2017

    Report

    Report Number
    3012307300-2017-02037
    Event Type
    Injury
    Date Received
    September 8, 2017
    Report Date
    September 8, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586028335
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MFR: 3012307300-2017-01997, 3012307300-2017-02035, 3012307300-2017-02036, 3012307300-2017-02038, 3012307300-2017-02039, 3012307300-2017-02040, 3012307300-2017-020341, 3012307300-2017-02042, 3012307300-2017-02043.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SITE ISSUES WITH A CLEO® 90 INFUSION SET. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE 33.3MMOL AT THE TIME OF THE EVENT. THERE WERE NO ALARMS INDICATING RISING BLOOD GLUCOSE LEVELS. THE PATIENT ALSO EXPERIENCED VOMITING, AND VISITED THE HOSPITAL. A PROBLEM WITH THE PATIENT'S PUMP WAS RULED OUT AS THE PUMP WAS "WORKING FINE". NO PERMANENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630967 CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 77X028 10610586028335

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other