BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEARLINK SYSTEM-CONTINU-FLO SOLUTION SET

    MDR report key: 510591 · Received February 10, 2004

    Report

    Report Number
    510591
    Event Type
    Death
    Date Received
    February 10, 2004
    Date of Event
    January 31, 2004
    Report Date
    February 10, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO ED WITH DYSPNEA, PERSISTENT COUGH AND RUNNY NOSE. PT RECEIVED ASSESSMENT AND TREATMENT THAT INCLUDED, ALB-ATROVENT TIMES 3 (2.5MG-UNIT DOSE), NS BOLUS 20 CC/KG, DECADRON 6MG, IV, TYLENOL 120 MG PO AND ALBUTEROL 10 MG TO RUN OVER 1 HOUR. LAB STUDIES AND CHEST X-RAY. PT STABILIZED WITH ADMISSION. ADMITTING H&P STARTED IN ED BY ADMITTING TEAM, PT FUSSY, OXYGEN TUBING BECAME DISCONNECTED FROM NEBULIZER TREATMENT, ATTEMPT TO RECONNECT UNSUCCESSFUL, INADVERTENTLY OXYGEN TUBING ATTACHED TO CLEARLINK PORT OF INTRAVENOUS TUBING. OXYGEN TUBING DISCONNECTED FROM IV TUBING WITHIN SECONDS, PT BECAME LIMP AND UNRESPONSIVE, CPR INITIATED WITHOUT RETURN OF SPONTANEOUS RESPIRATIONS OR PULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM-CONTINU-FLO SOLUTION SET INTRAVENOUS SOLUTION SET FPA BAXTER HEALTHCARE CORP 2C8537S UNK
    2 AIRLIFE-OXYGEN TUBING OXYGEN TUBING BYX ALLEGIANCE HEALTHCARE CORP UNK Y3P0184

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Death 1) OXYGEN CONNECTING TUBE.| 2) CLEARLINK SYSTEM-CONTINU FLO SOLUTION SET.