BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION SMARTSITE INFUSION SET

    MDR report key: 7159820 · Received January 2, 2018

    Report

    Report Number
    MW5074372
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    November 15, 2017
    Report Date
    December 21, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CAREFUSION TUBING REF # 2430-0500 DID NOT PRIME WHEN NTN ATTEMPTING TO PRIME IV FLUIDS THROUGH NEW PUMP SET. LOT # IS EITHER 17097762 OR 07613203011396 WITH EXP OF 09/30/2020. REF # 2430-0500. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: PREMATURITY OF BIRTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672 CAREFUSION SMARTSITE INFUSION SET INFUSION SET FPA CAREFUSION 17097762

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR