Medical Device Alert: Octopus 3 extension set with anti-reflux valves and clamps manufactured by Vygon (MDA/2011/113)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/113 or 2011/009/028/601/004

Technical aspects
Sharon Knight & Claire Dunne
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7202 / 7162
Fax: 020 8754 3965
Email: sharon.knight@mhra.gsi.gov.uk and claire.dunne@mhra.gsi.gov.uk

Clinical aspects
Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965
Email: nicola.lennard@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

Health 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

Possible failure to deliver therapy under gravity infusion, as these sets may be fitted with anti-syphon valves instead of anti-reflux valves.

The manufacturer issued a Field Safety Notice (FSN) for this device on 27/09/2011, 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.
• Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.

Action by

All healthcare workers who use these devices, and personnel involved in the purchase, supply and distribution of these devices.

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
• All wards
• Ambulance services directors
• Ambulance staff
• Anaesthesia, directors of
• Chief pharmacists
• Clinical governance leads
• Health and safety managers
• Hospital at home units
• Intensive care units
• IV nurse specialists
• Maternity units
• Medical directors
• Modern matrons
• Neonatal nurse specialists
• Nursing executive directors
• Nutritional nurse specialists
• Oncology units
• Outpatient clinics
• Outpatient theatre managers
• Palliative care teams
• Paramedics
• Pharmacists
• Radiology
• Resuscitation officers and trainers
• Risk managers
• Supplies managers
• Theatre managers

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

• Community children’s nurses
• Community hospitals
• Community midwives
• Community nurses
• District nurses
• Palliative care teams
• Walk-in centres

Independent distribution

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

• Adult placement
• Care homes providing nursing care (adults)
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

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.

Kate O’Connell
Vygon (UK) Ltd
The Pierre Simonet Building
V Park
Gateway North
Latham Road
Swindon SN25 4DL

Tel: 01793 748 800
Fax: 01793 748 899
Email: technical@vygon.co.uk

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