Auxiliary common gas outlet (ACGO) for anaesthetic machine - no fresh gas flow to patient with wrong setting

(GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)

CAS deadlines

Action underway: 9 December 2011, action complete: 16 December 2011

Device

Anaesthetic machine: Auxiliary Common Gas Outlet (ACGO).

All Aestiva, Aisys, Aespire and Avance anaesthetic machines.

Manufactured by GE Healthcare.

Problem

The accidental, incorrect setting of the ACGO switch will result in no fresh gas flow to the patient.

Furthermore, if the circle breathing circuit is incorrectly attached to the ACGO, this may result in patient barotrauma.

Action

If you have these machines, ensure that:

  • the position of the ACGO lever and breathing circuit connections are checked before the start of every case, as recommended by the manufacturers and in the Association of Anaesthetists of Great Britain and Ireland (AAGBI) pre-use checklist -  care is especially recommended for paediatric lists where breathing circuits are changed routinely between patients

  • relevant members of staff have been fully trained in the use of these anaesthetic machines and are aware of the manufacturer’s training guidance produced in collaboration with the Safety Committee of AAGBI – see appendix of PDF below.

Action by

Anaesthetic and theatre staff involved in the set-up and use of these devices.

Distribution

This MDA has been sent to:

  • NHS trusts in England (chief executives)

  • Care Quality Commission (CQC) (Headquarters) for information

  • HSC trusts in Northern Ireland (chief executives)

  • NHS boards in Scotland (equipment coordinators)

  • Local authorities in Scotland (equipment coordinators)

  • NHS boards and trusts in Wales (chief executives)

  • General practitioners (for information)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • A&E departments

  • Anaesthesia, directors of

  • Anaesthetic nursing staff

  • Anaesthetists

  • Day surgery units

  • Maternity units

  • Operating department practitioners

  • Recovery wards

  • Risk managers

  • Theatres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
• Hospitals in the independent sector
• Independent treatment centres

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Manufacturer contact

Paul Mardle, UK Regulatory Affairs
David Walker, UK Product Manager
GE Healthcare

Tel: 01707 263 570

Email: paul.mardle@med.ge.comor david.walker@med.ge.com

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/108 or 2011/006/027/401/017

Technical aspects

Douglas McIvor or Emma Rooke
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7193 / 6609
Fax: 020 8754 3965

Email: douglas.mcivor@mhra.gsi.gov.uk oremma.rooke@mhra.gsi.gov.uk

Clinical aspects

Tom Clutton-Brock
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7056
Fax: 020 8754 3965

Email: tom.clutton-brock@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices.

Further information about CAS can be found on the CAS website

Northern Ireland

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)Northern Ireland Adverse Incident Centre (NIAIC)

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)

Wales

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: Anaesthetic machine: Auxiliary Common Gas Outlet (ACGO) manufactured by GE Healthcare (MDA/2011/108) (504Kb)

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