BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET AND SECONDARY SET

    MDR report key: 2051512 · Received April 1, 2011

    Report

    Report Number
    2051512
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 29, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6), DOB (B)(6), FEMALE ADMITTED TO THE MEDICAL CENTER ON (B)(6) 2011 FOR TREATMENT ASSOCIATED WITH A 40% TOTAL BODY SURFACE BURN. ON (B)(6) 2011, BLOOD CULTURES DRAWN WERE POSITIVE FOR E-COLI AND IV ANTIBIOTIC TREATMENT WAS ORDERED; CEFAZOLIN 2000 MG Q 8 HOURS. NEW IV TUBING WAS HUNG ON (B)(6) 2011. ON (B)(6) 2011, STAFF NOTICED THAT ALTHOUGH THE MEDICATION WAS FLOWING FROM SECONDARY SET AS IT SHOULD WITH APPROPRIATE SETUP, IT WAS FLOWING INTO IV MAINTENANCE BAG RATHER THAN INFUSING THROUGH THE ALARIS PUMP AND INTO THE PATIENT. IV PUMP WAS REPLACED AND THE SAME PROBLEM STILL EXISTED. NEXT STAFF REPLACED THE IV SET WITH A NEW SET OF TUBING AND THE MEDICATION WAS DELIVERED AS ORDERED. STAFF FELT LIKE THE PROBLEM WAS WITH THE IV TUBING SET POSSIBLY AN ISSUE WITH THE BACK CHECK VALVE THAT SUPPOSE TO PREVENT FLUID FROM A SECONDARY BAG FROM FLOWING INTO A PRIMARY BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE INFUSION SET AND SECONDARY SET PRIMARY IV TUBING AND SECONDARY SET FPA CAREFUSION 10015489/11448964 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other