BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANESTHESIA EXTENSION SET-EXPAN

    MDR report key: 1592146 · Received January 13, 2010

    Report

    Report Number
    1417592-2010-00002
    Event Type
    Other
    Date Received
    January 13, 2010
    Date of Event
    December 14, 2009
    Report Date
    January 12, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGICAL CASE HAD BEEN INITIATED AND THE INCISION HAD BEEN MADE. THE PATIENT BEGAN TO EXHIBIT SIGNS OF INCREASED CO2 LEVELS AND THE CASE WAS ABORTED. THEY THEN REALIZED THAT THE ANESTHESIA CIRCUIT AND EXTENSION WAS ASSEMBLED INCORRECTLY. THIS ALLOWED FOR 500 CC OF DEAD SPACE AT THE END OF THE CIRCUIT. THE PATIENT DID WELL BUT HAD TO COME BACK THE NEXT DAY SO THAT THE ORIGINAL PLANNED PROCEDURE COULD TAKE PLACE. THE CIRCUIT WAS NOT ASSEMBLED CORRECTLY BY THE CLINICIAN AND AS A RESULT, CREATED APPROXIMATELY 500 CC OF DEAD SPACE AT THE PATIENT END OF THE CIRCUIT. THE EXPANDABLE TUBE SHOULD HAVE BEEN ATTACHED TO THE VENTILATOR END. THE CONTACT AT THE ACCOUNT COULD NOT COMMENT ON THE KNOWLEDGE LEVEL OF THE CLINICIAN WHO ASSEMBLED IT. BASED ON THE INFORMATION GATHERED FROM THE ACCOUNT, IT IS DETERMINED THAT THIS INCIDENT WAS THE RESULT OF USER ERROR. DUE TO THE FACT THAT THE PROCEDURE WAS ABORTED AND RESTARTED, THE FOLLOWING DAY, THIS MDR IS BEING FILED.

    Description of Event or Problem · 1

    AN EXTENSION TUBE WAS INCORRECTLY ATTACHED TO AN ANESTHESIA CIRCUIT WHICH ALLOWED 500 CCS OF DEAD SPACE AT THE PATIENT END OF THE CIRCUIT. THE PATIENT'S CO2 BECAME ELEVATED AND THE CASE WAS ABORTED WHILE THE ISSUE WAS BEING DIAGNOSED. THE PATIENT ENDURED AN ADDITIONAL PROCEDURE THE NEXT DAY TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA EXTENSION SET-EXPAN NONE CAI MEDLINE INDUSTRIES, INC. DYNJAA10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1