Medical Device Alert: Tec 6 Plus Desflurane vaporiser manufactured by GE Healthcare (MDA/2009/072)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/072 or 2009/002/020/601/001

Technical aspects
Douglas McIvor or 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
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 (external link).

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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

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

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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 (external link)

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

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

There is a higher than expected age related failure of an internal component, which has resulted in either over or under delivery of anaesthetic agent to patients.

GE Healthcare has found that the internal rotary valve has been failing prematurely. Whilst this failure rate is low, it is higher than expected with other types of vaporiser. It is usually perceived that anaesthetic vaporisers are extremely reliable; consequently anaesthetists have continued to use faulty vaporisers in the mistaken belief that it is their agent monitor that has failed.

• Identify all Tec 6 Plus Desflurane vaporisers.
• Ensure users are made aware of the increased failure rate of these devices.
• Have procedures in place to ensure that:
• • the vaporiser’s performance is closely monitored
  • the vaporiser is replaced immediately if any problem is suspected
  • the vaporiser performance is regularly checked, as recommended in its user reference manual in sections 6-2 and 6-3.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• 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:

• Anaesthesia, directors of
• Anaesthetic nursing staff
• Anaesthetists
• Operating department practitioners
• Risk managers
• Theatre managers

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

• Hospitals in the independent sector
• Independent treatment centres

Mr Paul Mardle
GE Healthcare
71 Great North Road
Hatfield
Herts
AL9 5EN

Tel: 01707 263 570
Fax: 01707 260 065

Email: paul.mardle@med.ge.com