BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION SMARTSITE EXTENSION

    MDR report key: 7237754 · Received February 1, 2018

    Report

    Report Number
    MW5075015
    Event Type
    Injury
    Date Received
    February 1, 2018
    Date of Event
    January 21, 2018
    Report Date
    January 31, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED ON (B)(6) 2018. TUBING WAS CONNECTED TO PT VIA CHEST PORT ON (B)(6) 2018 AT 1900. THERE WERE NO TUBING CHANGES LEADING UP TO THE EVENT. PT HAD BEEN RECEIVING DEXTROSE 5% SOD CHLORIDE 0.45% + POTASSIUM CHLORIDE 20MEQ RUNNING AT 28 MLS/HR, BUT AT 0106 AN IVPB OF CYCLOPHOSPHAMIDE 470MG WAS STARTED TO RUN AT 50 ML/HR FROM 0106. AT 0200 ASSESSMENT, RN NOTICED BLOOD WAS BACK FLOWING AND LEAKING OUT OF TUBING, UPON ASSESSMENT THE SMARTSITE ON THE Y-PORT OF THE EXTENSION TUBING HAD COME OFF/WERE MISSING CAUSING THE BLOOD BACKFLOW. RN CHANGED TUBING, AND ATTEMPTED TO FLUSH THE PORT. THE PORT WOULD NOT FLUSH OR DRAW BLOOD BACK AT THIS TIME. AFTER SEVERAL ATTEMPTS TO RE-ACCESS AND FLUSH, AN XRAY WAS PERFORMED TO CONFIRM PLACEMENT, AND THE MEDICAL TEAM ORDERED ALTEPLASE TO BE ADMINISTERED TO ATTEMPT TO DE-CLOT THE OCCLUDED PORT. EVEN WITH MULTIPLE ATTEMPTS, 0.1 ML OF THE 3ML TREATMENT (1 MG/ML OF ALTEPLASE +2 MLS OF 0.9% SODIUM CHLORIDE). IT WAS THEN ATTEMPTED TO RE-ACCESS ANOTHER TIME. GENERAL SURGERY HAD TO BE CONSULTED. PT HAD TO UNDERGO SURGICAL PROCEDURE WITH GENERAL ANESTHESIA ON (B)(6). PT HAD REMOVAL AND REPLACEMENT OF A RIGHT SUBCLAVIAN PORT. CAREFUSION SMARTSITE EXTENSION SET REF 30212E, LOT #1161801. THE SMARTSITE NEEDLE FREE VALVE OF THE Y-SITE OF THE TUBING WAS NO LONGER THERE. CHILD WAS SLEEPING IN THE ROOM W/GRANDMOTHER SLEEPING. RN STARTED CHEMO (CYCLOPHOSPHAMIDE) VIA SYRINGE, INFUSED AND READY TO FLUSH. RN HOOKS UP NORMAL SALINE FLUSH AND INITIATES. AROUND THE TIME THE FLUSH IS COMPLETE, SHE NOTICES BLOOD ON THE BED. THERE WAS A 13 MINS PERIOD BETWEEN STARTING THE FLUSH AND THE CATCH OF THE BLOOD BACK UP. THE MISSING PORTION OF THE TUBING WAS NOT FOUND; SUSPECTED THROWN OUT THE LINENS. TUBING WAS DISCONNECTED; PATENCY CHECK (ATTEMPTED NS FLUSH) REVEALED INABILITY TO FLUSH. RN AND CHARGE RN IMMEDIATELY ATTEMPTED REACCESSING, COULD NOT FLUSH OR HAVE BLOOD RETURN, THOUGH THEY FELT THEY WERE IN RIGHT AREA (BOTH STATE PORT IS SMALL AND HAD BEEN CHALLENGING TO ACCESS IN PAST, THOUGH NO EXPLICIT FUNCTIONALITY ISSUES). ATTEMPTED 3 MORE TIMES IN TREATMENT ROOM WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77862 CAREFUSION SMARTSITE EXTENSION CAREFUSION SMARTSITE EXTENSION S FPA CAREFUSION 11611801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention