Medical Device Alert: Infusion pumps: Plum A+ and A+3 family of infusers manufactured by Hospira (MDA/2013/006)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/006 or 2013/002/004/291/031

Technical aspects
Sharon Knight or Roopa Prabhakar
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7202/7293
Fax: 020 8754 3965
Email: sharon.knight@mhra.gsi.gov.uk or roopa.prabhakar@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 to treatment.

If the pump is running on mains power and the software detects that the battery cannot be fully recharged, an alarm will sound and the infusion will stop.

If this occurs the “E321” error message will be displayed.

The MHRA continues to investigate this and other recent field safety corrective actions.

• Identify affected pumps.
• Consider using an alternative device, particularly if an interruption to an infusion could compromise patient safety.
• If an alternative is not available, follow the advice in the manufacturer’s Field Safety Notice (845Kb) (dated 19 February 2013)
• Ensure staff also follow the advice in other Field Safety Notices issued by the manufacturer for the following problems: 
  • Volume control knob (457Kb)
  • Door roller assembly (2746Kb)
  • Distal pressure sensor calibration (61Kb)
  • Fluid ingress (991Kb)
  • Fluid shield diaphragm (84Kb)
  • Distal pressure sensor pin fracture (92Kb)
  • Recycling / rebooting (3252Kb)

Action by

All medical, nursing and technical staff involved in the use of these devices.

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)
• Primary care trusts in England (chief executives)

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
• Health visitors
• Hospital at home
• Palliative care teams

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