BEUDAMED
    FDA Adverse Event Summary report: N

    SMARTSITE BURETTE INFUSION SET

    MDR report key: 4790280 · Received May 21, 2015

    Report

    Report Number
    4790280
    Date Received
    May 21, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 21, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VANILLA TPN OBTAINED FROM PHARMACY FOR NICU LOW BIRTH WEIGHT PREMATURE PATIENT WITH VERY LOW BLOOD SUGAR. CENTRAL LINE FLUIDS ARE HUNG USING STERILE TECHNIQUE. RN WEARING PROPER PPE WAS PRIMING TUBING, VANILLA TPN BAG SPIKED WITH CUSTOM ALARIS ONE PIECE TUBING USED IN THE NICU. WHEN BEGINNING TO PRIME TUBING RN NOTED SMALL BLACK FOREIGN MATERIAL IN BURETTE. PRIMING STOPPED, PHARMACY NOTIFIED AND NEW VANILLA TPN ORDERED AND SENT. TUBING AND BAG FORWARDED TO RISK MANAGEMENT.PLEASE NOTE, IT IS UNKNOWN IF THIS SMALL FOREIGN OBJECT ORIGINATED IN THE IV FLUID BAG OR IF IT WAS IN THE BURETTE PRIOR TO PRIMING. THE TPN WAS PREPARED, THEN SENT TO PHARMACY FOR MEDICATION INJECTION, AND THEN TRANSPORTED TO NICU. THE OBJECT WAS NOTED DURING PRIMING.NO PATIENT HARM, EVENT DID NOT REACH PATIENT.======================MANUFACTURER RESPONSE FOR SMARTSITE BURETTE INFUSION SET, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================LEFT MESSAGE WITH CAREFUSION CUSTOMER ADVOCACY INTAKE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331787 SMARTSITE BURETTE INFUSION SET FLUID ADMINISTRATION SET FPA CAREFUSION H3701111812210 15025817

    Patients

    Seq Age Sex Outcome Treatment
    1 *