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
- 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
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.
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
Tel: 0800 917 8776
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
- 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
- Risk managers
- Special care baby units
- Supplies managers
Establishments registered with the Care Quality Commission (CQC) (England only):
- Care homes providing nursing care (adults)
- 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: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/006 or 2016/010/017/401/005.
Roopa Prabhakar or Emma Rooke, MHRA
Tel: 020 3080 7293/6609
Email: firstname.lastname@example.org or email@example.com
Mark Grumbridge, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England Through Yellow Card
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
Department of Health
Social Services and Public Safety
Tel: 028 9052 3868
Reporting adverse incidents in Northern Ireland Please report directly to NIAIC using the forms on our website.
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
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).