Medical Device Alert: Infusion pumps: Plum A+ single channel infuser systems manufactured by Hospira (MDA/2013/004)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/004 or 2012/010/029/081/030

Technical aspects
Roopa Prabhakar or Catriona Blake
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7293/7219
Fax: 020 8754 3965
Email: roopa.prabhakar@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Mark Grumbridge
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7128
Fax: 020 8754 3965
Email: mark.grumbridge@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

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 (IRIC) (external link)

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

Risk of interruption in therapy due to clinical staff failing to hear the alarm.

The operation of the alarm volume control is not consistent with the operator’s manual. On some pumps, the knob is turned clockwise to increase the volume, on others, it is anticlockwise.

Hospira will be updating the user manual and providing labels for each device to identify the correct operating direction.

• Ensure members of staff are aware that the alarm volume level control is not the same on all these pumps.
• Ensure that relevant members of staff are familiar with the steps to check the alarm as described in the manufacturer’s Field Safety Notice (dated 29 October 2012), in particular the need to confirm the volume level before beginning therapy.
• Contact Hospira to arrange for volume direction labels to be fixed to all devices.
• If you have more than one device being used in the same location and they do not have the same alarm volume control, you may contact Hospira for adjustment of the direction of the volume control to ensure consistency.

Action by

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)
• Health and Safety Executive
• Primary care trusts in England (chief executives)
• Social services in England (directors)

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
• Adult intensive care units
• All wards
• Biomedical engineering staff
• Biomedical science departments
• Clinical governance leads
• Day surgery units
• EBME departments
• Equipment stores
• In-house maintenance staff
• IV nurse specialists
• Maintenance staff
• Medical directors
• Nursing executive directors
• Oncology units
• Paediatric intensive care units
• Risk managers
• Supplies managers
• Theatres

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

• Community hospitals
• Equipment libraries and stores
• Hospital at home
• Palliative care teams

Social services
Liaison officers for onward distribution to all relevant staff including:

• Care management team managers
• Equipment supplies managers
• In-house residential care homes
• Loan store managers

Independent distribution

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

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

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.

John McIlvaney
Customer Services Manager
Hospira UK
Queensway
Royal Leamington Spa
CV31 3RW

Tel: 0800 028 7304
Fax: 0800 028 7305
Email: custserv@hospira.com