BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIRCUIT ADULT ANESTHESIA

    MDR report key: 1278329 · Received December 23, 2008

    Report

    Report Number
    1417592-2008-00044
    Event Type
    Other
    Date Received
    December 23, 2008
    Date of Event
    December 1, 2008
    Report Date
    December 18, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    CAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS INITIATED AND THE ANESTHESIA MACHINE ALARMED. THE CIRCUIT WAS CHANGED AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PATIENT WAS HAND BAGGED DURING THE CHANGE OF THE CIRCUIT. IT WAS REPORTED THERE WAS NO INJURY TO THE PATIENT. THE ISSUE WITH THE CIRCUIT WAS NOT IDENTIFIED UNTIL AFTER THE CASE BEGAN. THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS PUBLISHED A GUIDELINE CALLED THE RECOMMENDATIONS FOR PRE-ANESTHESIA CHECKOUT PROCEDURES OF 2008. IT STATES THAT PRIOR TO EACH USE, BREATHING SYSTEM PRESSURE AND LEAK TESTING BE PERFORMED, AS WELL AS VERIFICATION THAT GAS FLOWS PROPERLY THROUGH THE BREATHING CIRCUIT. THE FACILITY STATED THE CIRCUIT WAS NOT TESTED PRIOR TO THE INITIATION OF THE SURGICAL PROCEDURE BUT GOING FORWARD, THEY WILL MAKE THIS PART OF THEIR ROUTINE PROTOCOL. THE SAMPLE WAS EVALUATED. UPON VISUAL INSPECTION, AN ABNORMALITY WAS IDENTIFIED. THE INTERNAL TUBE OF THE CIRCUIT WAS FOUND TO BE TWISTED, WHICH BLOCKED AIRFLOW. A SUPPLIER CORRECTIVE ACTION WAS ISSUED TO THE MANUFACTURER. INSPECTIONS OF THIS PRODUCT WILL BE INCREASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL TUBING OF THE CIRCUIT DID NOT ALLOW AIR TO PASS THROUGH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCUIT ADULT ANESTHESIA NONE CAI MEDLINE INDUSTRIES, INC. DYNJAAF6340 08HD0020

    Patients

    Seq Age Sex Outcome Treatment
    1