All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine

Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps

Action

  • Identify all devices with the product codes listed in the FSN
  • Ensure hospital or Carefusion service specialist checks pumps as detailed in the FSN
  • Prioritise devices used in paediatric/neonatal/critical care areas and all devices more than three years old
  • Ensure hospital or CareFusion replace broken springs
  • Ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s updated preventative maintenance
  • Note that this alert replaces MDA/2017/003, which we published in February 2017

Action by

All staff who use these devices.

Deadlines for actions

Actions underway: 15 May 2017

Actions complete: 12 July 2017

Please note: These deadlines are for plans to be in place to complete the pump checks.

Device details

Product Name: Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pump Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005, 8007

Product Name: Asena™ GS, GH, CC, TIVA, PK Syringe Pumps Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005

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/2017/006 or 2016/010/017/401/005.

Technical aspects

Roopa Prabhakar or Emma Rooke, MHRA

Tel: 020 3080 7293/6609

Email: roopa.prabhakar@mhra.gov.uk or emma.rooke@mhra.gov.uk

Clinical aspects

Mark Grumbridge, MHRA

Tel: 020 3080 7274

Email: dct@mhra.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

https://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

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/2017/006

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.