BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTECH BI-FLO ETCO2 CANNULA

    MDR report key: 535727 · Received July 19, 2004

    Report

    Report Number
    2014730-2004-00006
    Event Type
    Other
    Date Received
    July 19, 2004
    Date of Event
    May 1, 2004
    Report Date
    July 16, 2004
    Manufacturer
    HUDSON RESPIRATORY CARE, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE'S AIDE HAD INADVERTENTLY CONNECTED A HUDSON RCI ETCO2 CANNULA TO THE PT'S IV LINE. THE MISCONNECTION WAS NOT DETECTED FOR 4 HOURS, WHEN THE PT BEGAN COMPLAINING OF CHEST TIGHTNESS AND DIFFICULTY BREATHING. LIQUID WAS DETECTED COMING FROM THE PT'S NOSE AND MOUTH. THE PT WAS TREATED OF CHF FOR A SHORT TIME AND GIVEN LASIX IV. THE FACILITY ACKNOWLEDGES THAT THIS WAS A USER ERROR AND THAT NO MEDICAL DEVICES SHOULD EVER BE CONNECTED WITHOUT TRACING THE LINES BACK TO THEIR POINT OF ORIGIN. UNFORTUNATELY, THE TWO DEVICES DO FIT TOGETHER, WHICH IS THE CONCERN FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTECH BI-FLO ETCO2 CANNULA CANNULA CCK HUDSON RESPIRATORY CARE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention BAXTER IV TUBING.