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:
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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
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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:
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NHS trusts in England (chief executives)
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Care Quality Commission (CQC) (Headquarters) for information
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HSC trusts in Northern Ireland (chief executives)
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NHS boards in Scotland (equipment coordinators)
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Local authorities in Scotland (equipment coordinators)
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NHS boards and trusts in Wales (chief executives)
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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:
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A&E departments
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Anaesthesia, directors of
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Anaesthetic nursing staff
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Anaesthetists
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Day surgery units
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Maternity units
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Operating department practitioners
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Recovery wards
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Risk managers
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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.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.gov.uk oremma.rooke@mhra.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.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
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
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