Medical Device Alert: T-piece connector incorporated into various breathing systems manufactured by Intersurgical Ltd (MDA/2010/009)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/009 or 2009/010/028/401/002.

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).

This range of products are solely distributed in Northern Ireland via Surgical Systems Ireland and they have made all their customers in the region aware of the issue and have had stock checked locally. But we still strongly recommend that you adhere to action point 4 'Always follow the manufacturer's pre-use checks, as recommended by the Association of Anaesthetics of Great Britain and 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 (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 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

Possible occlusion of the connector by a plastic membrane caused by a moulding fault during manufacture. This fault could prevent or restrict the gas flow to the patient.

• Ensure that there is a system in place to identify affected lots.
• Where affected lots are identified:
• • visually inspect the T-piece at the indicated position before use
  • if the T-piece is not occluded the device may be used
  • if the T-piece has any evidence of a plastic membrane do not use and return to the manufacturer for a replacement.
• Always follow the manufacturer's pre-use checks, as recommended by the Association of Anaesthetists of Great Britain and Ireland in their guidelines 'Checking Anaesthetic Equipment 3 (2004)'. This publication is available from the Association of Anaesthetists of Great Britain and Ireland website (external link).

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:

• A&E departments
• Adult intensive care units
• Anaesthesia, directors of
• Anaesthetic nursing staff
• Anaesthetists
• Coronary care departments
• Day surgery units
• High dependency units
• Operating department practitioners
• Paediatric intensive care units
• Risk managers
• Special care baby units
• Theatres

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

• Hospices
• Hospitals in the independent sector
• Independent treatment centres

Customer Care UK
Intersurgical Limited
Crane House
Molly Millars Lane
Wokingham
Berkshire
RG41 2RZ

Tel: 0118 9656 376
Fax: 0118 9656 356

Email: sop@intersurgical.co.uk