Medical Device Alert: Venturi air entrainment jet adapters manufactured by Lifecare Hospital Supplies Ltd (MDA/2011/102)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/102 or 2011/008/002/291/005.

Technical aspects
Mr Douglas McIvor or Mrs Ann Seeruttun
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7193 / 7161
Fax: 020 8754 3965

Email: douglas.mcivor@mhra.gsi.gov.uk or ann.seeruttun@mhra.gsi.gov.uk

Clinical aspects
Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 6800
Fax: 020 8754 3965
Email: susanne.ludgate@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 (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
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) (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

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

Potential for full or partial blockage of the Venturi oxygen outlet.

The manufacturer issued an updated Field Safety Notice (FSN) on 28 September 2011 to extend the recall of these devices but has not had sufficient confirmation from users that they have received and acted on this information.

A copy of the FSN is in the appendix of this alert, and it is also available on the MHRA website.

This alert has been issued in support of the manufacturer’s actions.

• Ensure that relevant members of staff are aware of the problem.
• Identify and quarantine affected devices.
• Return affected product to the manufacturer for replacement.

Action by
All staff involved in the provision of oxygen therapy and stores personnel.

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)
• Primary care trusts in England (chief executives)

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
• Adult intensive care units
• All wards
• Coronary care departments
• Day surgery units
• Directors of nursing
• Intensive care units
• Maternity units
• Medical directors
• Paramedics
• Resuscitation officers and trainers
• Risk managers
• Theatres

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

• Community hospitals
• Community midwives
• Minor injury units
• NHS walk-in centres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• Hospices
• 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.

Mr Gino Ostacchini
Regulatory/Quality Assurance Manager
Lifecare Hospital Supplies
Edinburgh Way
Harlow
Essex
CN20 2TT

Tel: 01279 414 969
Fax: 01279 635 232
Email: gostacchini@clement-clarke.com

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