BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO

    MDR report key: 910467 · Received September 7, 2007

    Report

    Report Number
    910467
    Event Type
    Malfunction
    Date Received
    September 7, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 7, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CALLED OUT "MY LINE IS BROKE." UPON ENTERING THE ROOM THE RN FOUND SOLUTION SET TUBING TO HAVE SNAPPED DOWN AT THE LAST HARD PLASTIC CONNECTION WHERE TUBING CONNECTS TO PATIENT. CYTOSAR RUNNING AT TIME. STOPPED CYTOSAR MEDICATION. MEDICATION RUNNING OUT OF BROVIAC END AS WELL. RN CLAMPED BLUE LUMEN OF RIGHT DOUBLE LUMEN BROVIAC (R DLB). FLUSHED LINE WITH 3 ML OF NORMAL SALINE (NS) AND 3 ML HEPARIN 10:1. MD AWARE. A FEW DROPS FELL ON THE PATIENT'S BELONGINGS. CHEMOTHERAPY SPILL KIT USED. PATIENT STATED "SNAPPED WHEN THEY MOVED STUFFED ANIMAL TO PLACE UNDER LINE." THE PATIENT STATES THEY DID NOT PULL ON THE R DLB. STATED NO TENSION PLACED ON LINE. TUBING GIVEN TO PRODUCTS UTILIZATION MANAGER FOR RETURN TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO TUBING, IV FPA BAXTER HEALTHCARE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR CHEMOTHERAPY