BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 4152615 · Received October 2, 2014

    Report

    Report Number
    MW5038510
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ANTIBIOTIC BAG SPIKED AND LINE BLED, ATTACHED TO PT'S MIDLINE IV. IV PUMP BEGAN TO BEEP WITH CHECK LINE, OPENED PUMP AND FOUND "STRETCHY PART" OF TUBING HAD DIME SIZE BALLOON WHICH THEN POPPED, SPRAYING ANTIBIOTIC. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614143 SMARTSITE INFUSION SET SMARTSITE INFUSION SET FPA CAREFUSION 2426-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR ALARIS INFUSION PUMP