Medical Device Alert: Enteral feeding administration sets and Applix Smart pump sets manufactured by Fresenius Kabi (MDA/2010/028)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/028 or 2010/001/026/081/003.

Technical aspects
Nicole Small or Sharon Knight
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3310
Fax: 020 7084 3202

Email: nicole.small@mhra.gsi.gov.uk or sharon.knight@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & 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
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)

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

Risk of non-delivery of enteral feed.

Due to a manufacturing problem, the antifree flow clamp may not automatically open when the set is inserted into the enteral feed pump and its door is closed.

Fresenius Kabi issued a Field Safety Notice to customers in November 2009. This included direct communication to known patients in the community as part of the Fresenius Kabi home enteral feeding service.

The manufacturer’s notice provided guidance on checking for flow of fluid in the administration set following priming of the set using the pump only but omitted to include actions to be taken when priming the set by gravity.

This Medical Device Alert has been issued to ensure that all end users are aware of the problem and that they observe flow of fluid in the tubing following priming either by gravity or by using the pump.

• After starting the pump, check for flow of fluid in the drip chamber and in the tubing exiting the pump. This applies if the set is primed by the pump or by gravity.
• If there is no flow, replace the set, quarantine the faulty set and report the problem to the MHRA.

This MDA has been distributed to:

NHS trusts in England (Chief Executives)

• 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 wards
• Clinical governance leads
• Dietetics departments
• EBME departments
• Hospital at home units
• Hospital pharmacists
• Intensive care nursing staff (adult)
• Intensive care nursing staff (paediatric)
• Nursing executive directors
• Nutrition nurses
• Palliative care teams
• Purchasing managers
• Risk managers
• Supplies 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
• Nursing agencies

OFSTED to:
The MHRA considers this to be important to:

• Children’s services
• Educational establishments with beds for children
• Residential special schools

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

• Community children’s nurses
• Community hospitals
• Community pharmacists
• District nurses
• Nutritional nurse specialists
• Palliative care teams

Customer Services
Fresenius Kabi
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT

Tel: 01928 533 697
Fax: 01928 533 420

Email: Customer.Services-UK@Fresenius-Kabi.com