Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser - CE marking withdrawn

(Hospira) Use an alternative pump, where available. (MDA/2013/078)

CAS deadlines

Action underway: 18 November 2013, action complete: 16 December 2013

Note: These deadlines are for systems to be in place to identify pumps and ensure users are aware of the problems.

Device

Infusion pumps.

Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser.

Manufactured by Hospira. All models and list numbers.

Problem

The CE marking for these pumps has been withdrawn.

Hospira will not be able to supply any new pumps. However, they can continue to supply consumables for pumps already in use.

There are a number of current Field Safety Notices detailing faults that may lead to over-infusion, low infusion rates or an interruption to therapy. The manufacturer’s proposed corrective actions for the Plum pumps (which include design changes) will not be carried out in the UK at this time, as their safety and performance have not been subjected to independent assessment by a notified body.

In March 2013 the MHRA issued Medical Device Alert MDA/2013/016 in relation to the Gemstar infusers. The relevant Field Safety Notices are:

In February 2013 we issued MDA/2013/006 in relation to the Plum A+ and A+3 family of infusers. The relevant Field Safety Notices are:

Action

Gemstar and Plum pumps

  • Use an alternative pump, where available.
  • If an alternative is not available:
    • assess the risks/benefits associated with the use of these pumps for each individual patient when administering therapies
    • ensure that staff are aware of all the issues highlighted in the manufacturer’s Field Safety Notices, and MDA/2013/006 and MDA/2013/016
    • exercise caution in use
    • report any adverse incidents involving these devices to the MHRA.

Gemstar pump only

  • Hospira are offering the Sapphire pump, manufactured by Q Care, on a part exchange basis.
  • Contact Hospira to discuss options for your hospital.

Action by

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

Distribution

This MDA has been sent to:  

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment co-ordinators)
  • NHS England area teams for information
  • NHS 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 libraries and 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

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.

Manufacturer contact

Manufacturer’s authorised representative

John McIlvaney
Customer Services Manager
Hospira UK
Queensway
Royal Leamington Spa

Tel: 0800 028 7304               

Email: custserv@hospira.com

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/078 or 2013/002/004/291/031

Technical aspects

Sharon Knight or Catriona Blake
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7202/7219     
Fax: 020 8754 3965

Email: sharon.knight@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 

Northern Ireland

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
Further information about SABS can be found on the SABS website

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
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

Wales

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

Download documents

Medical Device Alert: Infusion pumps - Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser manufactured by Hospira (MDA/2013/078) (61Kb)

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