Anaesthetic vaporisers - failure to attach vaporisers to the anaesthetic machine causes gas leakage according to reports

(All manufacturers) reports received: failure to correctly attach vaporisers to the anaesthetic machine backbar has led to anaesthetic gas leakage and patient awareness. (MDA/2010/052)

Device

Anaesthetic vaporizers used to administer volatile agents for the maintenance of anaesthesia - all manufacturers.

Problem

The MHRA has received reports where the failure to correctly attach vaporizers to the anaesthetic machine backbar has led to anaesthetic gas leakage and patient awareness.

This may be more pronounced where:

  • vaporizers are attached to anaesthetic machines from an alternative manufacturer
  • vaporizers are attached to the backbar during anaesthsia.

Action

  • Ensure that vaporizers are correctly seated on the backbar before the induction of anaesthesia and that the machine has been tested for leaks in accordance with the manufacturer’s instructions and the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Guidelines.
  • If a new vaporizer is attached to the backbar during anaesthesia, the machine must be checked immediately in accordance with the manufacturer’s instructions and the AAGBI GuidelinesAAGBI Guidelines .

The AAGBI Guideline “Checking Anaesthesia Equipment” is under revision. The testing for leaks by occluding the Common Gas Outlet may not always be appropriate, therefore always consult the instructions for use of the vaporizer and the anaesthetic machine.

Distribution

This MDA has been distributed to:

  • NHS trusts in England (Chief Executives)
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Chief Executives)
  • NHS boards and trusts in Wales (Chief Executives)

Onward distribution

Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

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

  • Anaesthetic nursing staff
  • Anaesthetists
  • Clinical perfusion scientists
  • Day surgery units
  • Operating department practitioners.
  • Theatre managers
  • Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

  • Hospitals in the independent sector

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/2010/052 or 2008/012/011/401/021.

Technical aspects

Mr Douglas McIvor or Dr Louise Mulroy
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3193 / 3344
Fax: 020 7084 3209

Email: douglas.mcivor@mhra.gsi.gov.uk or louise.mulroy@mhra.gsi.gov.uk

Clinical aspects

Dr Tom Clutton-Brock
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3056
Fax: 020 7084 3111

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 Central Alerting System 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)

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website .

Further information about SABS can be found on the SABS website .

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 .

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 vaporizers - all manufacturers (MDA/2010/052) (177Kb)

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