BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 6205059 · Received December 27, 2016

    Report

    Report Number
    6205059
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 22, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD AND LIPID WERE NOTED TO BE BACKING UP INTO TOTAL PARENTERAL NUTRITION (TPN) LINE. TPN EXTENSION SET WAS FOUND TO BE LEAKING AT THE CONNECTION SITE. ON CLOSER INSPECTION, CONNECTION HUB WAS FOUND TO BE CRACKED. INFUSION STOPPED. CHARGE NURSE NOTIFIED. CHARGE NURSE ATTEMPTED TO FLUSH PICC LINE WITH NORMAL SALINE (NS). PICC LINE WAS FOUND TO BE CLOTTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856343 ALARIS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR