BEUDAMED
    FDA Adverse Event Death Summary report: N

    CODAN NICU MEDICATION ADMIN SET

    MDR report key: 20674337 · Received November 13, 2024

    Report

    Report Number
    MW5162406
    Event Type
    Death
    Date Received
    November 13, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 8, 2024
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 THE BLUE CLAMP LINE OF THE NICU MEDICATION ADMINISTRATION CODAN SET A327 (QUAD SET) WAS NOTED TO BE BROKEN/DISCONNECTED FROM THE CONNECTOR AT THE TERMINAL END OF THE SET. QUAD SET WAS REMOVED. NEW QUAD SET WAS ADDED AND NEW FLUIDS WERE HUNG. ON (B)(6) 2024 THE NICU MEDICATION ADMINISTRATION CODAN SET A327 WAS NOTED TO BE LEAKING AT THE CONNECTOR WITH POOLING AND RETROGRADE BACK FLOW OF INTRALIPIDS INTO THE OTHER THREE LINES NOTED. QUAD SET WAS REMOVED. BLOOD CULTURES DRAWN ON (B)(6) 2024 WERE POSITIVE FOR CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION (CLABSI). PATIENT WAS TRANSFERRED TO OUTSIDE FACILITY AND PASSED AWAY ON (B)(6) 2024. REF REPORT MW5162405.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995874 CODAN NICU MEDICATION ADMIN SET SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION A327

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Male Life Threatening| H| R| D