Medical Device Alert: Colleague single and triple-channel volumetric infusion pumps manufactured by Baxter (MDA/2009/035)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/035 or 2009/001/023/291/009.

Technical aspects
Ms Enitan Taiwo and Dr Catriona Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3122/3219
Fax: 020 7084 3209
E-mail: enitan.taiwo@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

How to report adverse incidents Please report via our website http://www.mhra.gov.uk

Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

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
E-mail: NIAIC@dhsspsni.gov.uk
http://www.dhsspsni.gov.uk/index/hea/niaic.htm

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
E-mail: iric@shs.csa.scot.nhs.uk
http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922
E-mail: Haz-Aic@wales.gsi.gov.uk

Risk of interruption of infusions due to:

1. software faults resulting in the pump stopping and alarming. It may not be possible to restart an affected pump.
2. increased occurrence of ‘damaged battery’ messages.
3. damage from improper cleaning.

The details of the three problems are:

1. The pumps can stop and alarm in the following ways:

• Failure codes 703:00, 701:00, 701:01 401:317:850:0000 and 403:317:871:0000 are caused by internal communications errors and the user cannot prevent these from occurring.
• Failure codes FC4:311:1545:XXXX or FC4:311:1985:5353 are software errors that occur under specific circumstances associated with piggyback infusions. The latest revision of UI Master software (5.09.92, 6.13.92) provides a correction for these failures.

2. Failure to install new batteries and a new battery harness following the message ’DAMAGED BATTERY! SERVICE NOW’ may lead to unpredictable battery performance and potential interruption of therapy.

3. Incorrect cleaning methods can cause fluid to enter the pump, which can lead to electrical short circuits, overheating and consequent malfunction.

• Ensure that a back-up pump is available at all times when these Baxter Colleague pumps are used.
• Ensure users are aware of Baxter’s instructions in their Field Safety Notice dated 26/1/09:

› Infusion systems: infusion pump - Baxter Healthcare - Colleague

1. Follow Baxter’s instructions on how to mitigate the consequences of pumps alarming and stopping for a range of failure code messages. Check the software version used by the pumps. If it doesn’t use the latest revision of UI Master software (5.09.92, 6.13.92 at time of publication), contact Baxter.

2. When the message ‘DAMAGED BATTERY! SERVICE NOW’ appears you must take the affected pump out of service and install new batteries with their new battery harness prior to clearing the damaged battery message. Contact Baxter to arrange training materials on battery management if you have not already received it (see Baxter’s Field Safety Notice).

3. Follow the instructions for proper cleaning provided in Baxter’s Field Safety Notice.

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)
• 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:

• Accident & emergency departments
• Adult & paediatric intensive care units
• All wards • Clinical governance leads
• Directors of anaesthetics
• Equipment libraries, stores and EBME departments
• IV specialist nurses
• Medical directors
• Nursing executive directors
• Outpatient departments
• Risk managers
• Special care baby units
• Theatres

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate 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

Change of address or removal from address list for Care Quality Commission:
National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61
E-mail: enquiries@cqc.org.uk

Manufacturer

Surecall-Baxter Medical Information
Baxter Healthcare Ltd
Wallingford Road
Compton Newbury
Berkshire
RG20 7QW

Tel: 01635 206 345
Fax: 01635 206 071
E-mail: surecall@baxter.com