Alaris® syringe pumps (GH, CC, TIVA & PK models) – risk of uncontrolled bolus of medicine.

Manufactured by CareFusion – Updates and replaces MDA/2016/023 as the manufacturer has now identified the potential for unintended bolus of medication when any syringe type is used in a pump that contains a broken spring in the plunger assembly.

Action

  • Contact CareFusion to discuss how to check the springs housed in the plunger holder.

  • If a broken spring is identified, contact CareFusion to arrange for the faulty springs to be replaced.

  • Ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s recommendations.

  • Note that this alert replaces MDA/2016/023, which we published in December 2016.

Action by

All those who use these devices.

Deadlines for actions

Actions underway: 13 March 2017

Actions complete: 26 April 2017

Problem / background

Since we published MDA/2016/023, the manufacturer has identified the potential for a broken spring in the plunger assembly to cause an unintended movement of the syringe plunger, which may result in a bolus of up to 0.5ml. This problem may be significant in the treatment of paediatric patients.

This issue may affect all syringes (recommended and non-recommended) when used in the specified Alaris syringe pumps.

Manufacturer contacts

CareFusion
Tel: 0800 917 8776

Email UK-customer-service@carefusion.com

Distribution

If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.

Trusts (NHS boards in Scotland)

CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • A&E departments
  • Adult intensive care units
  • All wards
  • Anaesthetists
  • Biomedical engineering staff
  • Clinical governance leads
  • Day surgery units
  • EBME departments
  • Equipment stores
  • IV nurse specialists
  • Medical directors
  • Neonatology departments
  • Nursing executive directors
  • Paediatric intensive care units
  • Paediatric wards
  • Paediatricians
  • Risk managers
  • Special care baby units
  • Supplies managers
  • Theatres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only):

  • 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.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2017/003 or 2016/010/017/401/005.

Technical aspects

Roopa Prabhakar or Jenifer Hannon, MHRA

Tel: Tel: 020 3080 7293 / 020 3080 7153

Email: roopa.prabhakar@mhra.gsi.gov.uk or jenifer.hannon@mhra.gsi.gov.uk

Clinical aspects

Mark Grumbridge

Tel: 020 3080 7274

Email: DCT@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NI SABS system

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre,
CMO Group,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Web: www.health-ni.gov.uk/niaic

Reporting adverse incidents in Northern Ireland

Please report directly to NIAIC using the forms on our 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
Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government
Tel: 02920 823 624 / 02920 825 510

Email:Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales)

Download document

MDA/2017/003

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