BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE LUMEN 12 FR. CANNULA

    MDR report key: 497590 · Received November 17, 2003

    Report

    Report Number
    MW1030243
    Event Type
    Malfunction
    Date Received
    November 17, 2003
    Date of Event
    September 29, 2003
    Report Date
    November 6, 2003
    Manufacturer
    ORIGEN BIOMEDICAL INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS CANNULATED FOR V-V ECMO, THE CANNULA WAS CONNECTED TO THE ECMO CIRCUIT AND SUPPORT WAS INITIATED. THE VENOUS SATURATION OF THE CIRCUIT WAS NOTED TO BE HIGH, 98% AND GREATER. THIS WAS DONE WITHOUT IMPROVEMENT. A CXR WAS DONE. THE CANNULA WAS THEN WITHRAWN 3 CM AS INDICATED BY THE CXR. THE HIGH VENOUS SATURATION DID NOT RESOLVE WITH THIS MANEUVER. AT THIS TIME IT WAS NOTED THE REINFUSION LINE PRESSURE WAS LOW. THE PRESSURE MONITOR WAS REZEROED AND FLOW WAS VERIFIED BY FLOWMETER. THERE WAS CONCERN THAT THERE WAS A COMMUNICATION BETWEEN THE LUMENS OF THE DOUBLE LUMEN CANNULA. TO BE SURE THIS WAS NOT DUE TO CANNULA POSITION OR AN ANATOMIC ISSUE WITH THE PT, A CARDIAC ECHO WAS DONE WITHOUT RESOLUTION. THE DECISION WAS THEN MADE TO CHANGE THAT CANNULA. THIS WAS ACCOMPLISHED WITHOUT INCIDENT. FLUID INJECTED INTO THE REINFUSION LUMEN WAS EVIDENT IN THE DRAINAGE LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN 12 FR. CANNULA DOUBLE LUMEN 12 FR. CANNULA DWF ORIGEN BIOMEDICAL INC. VV 12 F 36BC20121

    Patients

    Seq Age Sex Outcome Treatment
    1 *