Medical Device Alert: Alaris GP and Alaris GP Guardrails volumetric pump, manufactured by CareFusion, branded as Cardinal Health (MDA/2010/034)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/034 or 2010/002/002/081/015.

Technical aspects
Sharon Knight and Jim Lefever
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3202/3262
Fax: 020 7084 3209

Email: sharon.knight@mhra.gsi.gov.uk or jim.lefever@mhra.gsi.gov.uk

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

Due to a software irregularity, if the previous set up is not cleared at start-up, the single bubble detection threshold will default to 100 microlitres, without any indication to the user.

If the desired setting is less than 100 microlitres, there is the potential for serious injury, particularly to neonates.

If the desired setting is greater than 100 microlitres, there is the potential for an increase in nuisance alarms.

At start-up, the user is given the opportunity to clear setup. If the user selects ‘no’, thereby retaining the previous profile and infusion parameters, the single bubble detection threshold will default to 100 microlitres.

CareFusion has initiated a software upgrade programme and issued a Field Safety Notice in February 2010; the MHRA has issued this Medical Device Alert to support CareFusion’s actions.

• Locate affected pumps and contact CareFusion to arrange for the software to be upgraded
• Ensure that users are aware of the manufacturer’s Field Safety Notice.

• Follow the directions in CareFusion’s Field Safety Notice (February 2010) to re-programme infusion parameters for every new infusion.
• Put procedures in place to ensure that an air venting filter is used in the IV line when an infusion of air below 100 microlitres would be clinically significant, for example in neonates.

CareFusion will contact customers to make arrangements for the software upgrade.

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:

• A&E departments
• adult intensive care units
• all wards
• anaesthesia, directors of
• biomedical engineering staff
• clinical governance leads
• EBME departments
• equipment stores
• health and safety managers
• in-house maintenance staff
• IV nurse specialists
• medical directors
• medical libraries
• nursing executive directors
• outpatient departments
• paediatric intensive care units
• risk managers
• special care baby units
• supplies managers
• theatres

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

• care homes providing nursing care
• clinics
• hospices
• hospitals in the independent sector

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

• clinical governance leads
• community hospitals

Peter Highmoor
Director of Customer Support UK and Ireland
Carefusion
The Crescent
Jays Close
Basingstoke
Hampshire
RG22 4BS

Tel: 01256 388 398
Fax: 01256 388 388

Email: peter.highmoor@carefusion.com