BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANCE CS2

    MDR report key: 4350643 · Received December 22, 2014

    Report

    Report Number
    2112667-2014-00125
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    December 5, 2014
    Report Date
    December 6, 2014
    Manufacturer
    DATEX-OHMEDA, INC
    Product Code
    BSZ
    PMA / PMN Number
    K123125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND FOUND IT TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATIONS. LOGS WERE DOWNLOADED AND FORWARDED TO THE MANUFACTURING SITE FOR ANALYSIS. THE LOGS RECORD THAT, DURING THE REPORTED EVENT, THE DEVICE WAS ALARMING, NOTIFYING THE USER OF THE REPORTED CONDITION. THE DEVICE LOGS DO NOT RECORD ANY INTERNAL MALFUNCTIONS OR ERRORS. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS DUE TO A USE ERROR (IMPROPERLY CONNECTING THE PATIENT BREATHING CIRCUIT FROM THE INSPIRATORY PORT TO THE ACGO PORT PREVENTING PROPER PRESSURE RELIEF). THE ACGO PORT IS LABELED WITH A GRAPHIC THAT ILLUSTRATES HOW TO PROPERLY CONNECT A PATIENT BREATHING CIRCUIT TO THE INSPIRATORY AND EXPIRATORY PORTS, AND HOW TO PROPERLY CONNECT A NON-CIRCLE BREATHING DEVICE TO THE ACGO PORT. A PREOPERATIVE CHECKOUT OF THE EQUIPMENT, AS CONTAINED IN THE ADVANCE USER REFERENCE MANUAL, WILL PICK UP SUCH A MISCONNECT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, PRIOR TO INTUBATION, THE PATIENT WAS MANUALLY VENTILATED FOR APPROXIMATELY 5 MINUTES. ONCE THE PATIENT WAS INTUBATED, THE PATIENT'S CO2 LEVEL WAS NOT WHERE THE CLINICIAN EXPECTED IT TO BE. THE ENDOTRACHEAL TUBE WAS REPORTEDLY REMOVED, AND THE PATIENT WAS MANUALLY VENTILATED FOR A PERIOD OF TIME. THE PATIENT WAS THEN REPORTEDLY REINTUBATED, AND THE CO2 DID NOT IMPROVE. THE PATIENT WAS AGAIN MANUALLY VENTILATED, AND THE PATIENT WAS SCOPED AND REINTUBATED. THE CO2 DID NOT IMPROVE. AT THIS POINT, IT WAS REPORTEDLY POINTED OUT TO THE ANESTHESIOLOGIST THAT THE BREATHING CIRCUIT HOSE WAS MISCONNECTED. SUBSEQUENTLY, THE HOSE WAS CONNECTED PROPERLY. A LAPAROSCOPE WAS THEN PLACED TO BEGIN THE SURGICAL PROCEDURE. IT WAS THEN REPORTEDLY NOTED BY THE SURGEON THAT THE PATIENT'S DIAPHRAGM WAS NOT AS IT SHOULD BE. A CHEST X-RAY WAS PERFORMED, AND A TENSION PNEUMOTHORAX WAS REPORTEDLY NOTED. THE CASE WAS CANCELLED. THE PATIENT HAS REPORTEDLY RECOVERED AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840694 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention