BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 5220110 · Received November 12, 2015

    Report

    Report Number
    9616066-2015-01516
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    September 23, 2015
    Report Date
    October 26, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K801614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BAXA CORPORATION 500 ML EXACTAMIX BAG (ORDER # (B)(4)); THERAPY DATE (B)(6) 2015. THE CUSTOMER¿S REPORT OF A LEAK WAS NOT CONFIRMED. VISUAL INSPECTION REVEALED NO ANOMALIES. FUNCTIONAL TESTING FOUND NO LEAKS DURING THE GRAVITY RUN OR DURING THE INFUSION. LEAK TESTING FURTHER CONFIRMED THE RESULTS OF FUNCTIONAL TESTING AS THERE WERE NO LEAKS AT ANY PRESSURE UP TO 30 PSI. THE ROOT CAUSE OF THE LEAK WAS NOT CONFIRMED AS THE SET FUNCTIONED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IV TUBING LEAKED TPN SOLUTION AT THE CONNECTION CLOSEST TO THE NICU PATIENTS PORT ACCESS. NO PATIENT HARM REPORTED BY CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE INFUSING TPN THE NURSE NOTICED LEAKING COMING FROM THE IV EXTENSION SET. NO PATIENT HARM REPORTED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749497 SMARTSITE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 20027E

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA