BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMARTSITE

    MDR report key: 3113359 · Received May 8, 2013

    Report

    Report Number
    3113359
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    March 31, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV TUBING BALLOONED OUT WHILE INSIDE CHAMBER OF IV PUMP. IV PUMP WAS BEEPING OCCLUSION. TUBING REMOVED. CHEMOTHERAPY WAS INFUSING, SO TUBING WAS DISCARDED. CHEMO WAS INFUSING THROUGH PORTACATH AND NURSE NOTED SOME NEEDLE RESISTANCE. THE IV TUBING IS PRIMED BY PHARMACY WITH SALINE THEN SENT TO THE NURSING UNIT. THIS OCCURRED AT THE BEGINNING OF THE INFUSION. NO PATIENT HARM. THE NURSES HAVE NOT SEEN THIS HAPPEN PRIOR TO THIS EVENT. SINCE THIS EVENT, THERE HAVE BEEN A TOTAL OF THREE EVENTS LIKE THIS AT THIS FACILITY WITH THIS EQUIPMENT.======================MANUFACTURER RESPONSE FOR SMARTSITE INFUSION SET, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================NO RESPONSE AS OF YET. FILLED OUT CAREFUSION PAPERWORK SPECIFICALLY FOR "BALLOONED/ BULGING SILICONE TUBING ISSUE WITH AN ALARIS IV ADMINISTRATION SET".DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200052 ALARIS SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR ALARIS IV SMART PUMP