GemStar infusion system - risk of over-infusion, low infusion rates or an interruption of infusion

(Hospira) Due to pump faults. (MDA/2013/016)

CAS deadlines

Action underway: 9 April 2013, action complete:26 April 2013

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

Device

GemStar infusion system

Infusion pumps: GemStar infusion system.

Manufactured by Hospira.

All list numbers are affected.

Problem

The following pump faults may lead to over-infusion, low infusion rates or an interruption of infusion:

  • occlusion detection problems, due to pressure sensor calibration drift;
  • pump failure without warning, due to leaking batteries;
  • voltage of lithium battery dropping below 2.4 volts, causing pump to cease functioning;
  • an error with the pump’s motor assembly potentially causing the motor to rotate backwards at flow rates of less than 2 ml/hr.

The MHRA continues to investigate this and other recent Field Safety Corrective Actions implemented by Hospira.

Action

Identify affected pumps

Do not use these pumps on neonates and infants aged 2 years and under.

Do not use flow rates of less than 2 ml/hour.

Consider using an alternative device, particularly if an an over/under infusion, or an interruption to an infusion could compromise patient safety.

If an alternative is not available, follow the advice in each of the manufacturer’s Field Safety Notices.

Action by

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

Distribution

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)

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 clinical departments
  • 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
  • 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.

Manufacturer contact

John McIlvaney
Customer Services Manager
Hospira UK
Queensway
Royal Leamington Spa

Tel: 0800 028 7304
Fax: 0800 028 7305

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/2013/016 or 2013/003/008/081/001

Technical aspects

Roopa Prabhakar or Sharon Knight
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7293 / 7202
Fax: 020 8754 3965

Email: roopa.prabhakar@mhra.gsi.gov.uk or sharon.knight@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
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)

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: GemStar infusion system manufactured by Hospira (MDA/2013/016) (79Kb)

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