Medical Device Alert: All pole clamps for Infusomat Space and Perfusor Space infusion pumps manufactured by B Braun (MDA/2010/007)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/007 or 2009/009/018/401/015.

Technical aspects
Nicole Small or Richard Glover
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3310 / 3245
Fax: 020 7084 3209

Email: nicole.small@mhra.gsi.gov.uk or richard.glover@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@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 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

• Ensure that the pump is secured by the pole clamp as recommended in the manufacturer’s instructions for use.
• Distribute B Braun’s information poster to users.
• Inspect all affected devices. If components are damaged or missing, remove it from use and return the pole clamp to B Braun for repair.

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)
• Primary care trusts in England (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:

• All clinical departments
• All wards
• Ambulance staff
• Anaesthetic medical staff
• Anaesthetic nursing staff
• Biomedical engineering staff
• Biomedical science departments
• Clinical governance leads
• Day surgery units
• EBME departments
• Equipment stores
• Hospital at home units
• Intensive care units
• IV nurse specialists
• Medical physics departments
• Risk managers
• Special care baby units
• Theatre managers

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

• Care homes providing nursing care (adults)
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Nursing agencies

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

• Community hospitals
• District nurses
• Equipment libraries and stores
• Palliative care team

Quality Team
B Braun Medical Ltd
Thorncliffe Park
Sheffield
S35 2PW

Tel: 0114 225 9155
Fax: 0114 225 9136

Email: catherine.clulow@bbraun.com