- Identify affected pumps, which were manufactured from 29 April 2015 to 25 October 2016 inclusive – see the spreadsheet listing device serial numbers which accompanies this Medical Device Alert and the manufacturer’s Field Safety Notice (FSN). If you are still unsure, contact the manufacturer.
- Inspect affected pumps as detailed in the FSN. If a loose connectivity engine module or blank display is found, remove the pump immediately from service, and contact manufacturer for repair.
- If the pump powers down without an alarm, use an alternative pump, and contact manufacturer for repair.
- Assist manufacturer to schedule appointments for inspection/repair and ensure pumps are made available to manufacturer for inspection/repair at the scheduled time/date.
- Ensure you have read the Field Safety Notice and have completed and returned the acknowledgement form as currently the manufacturer has not received sufficient responses
All medical, nursing and technical staff involved in the use of these devices.
Deadlines for actions
Actions underway: 08 March 2018
Actions complete: 15 March 2018
Note: These deadlines are for users to have an action plan in place and not for the repairs to be complete.
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
The manufacturer provided a customised list of serial numbers with the FSN in June 2017. To identify affected devices either refer to the customised list, or review the attached spreadsheet below.
ICU Medical Customer Service
Tel: 020 3357 9400
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- A&E nurses
- Adult intensive care units
- All departments
- All wards
- Ambulance services directors
- Ambulance staff
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anti-coagulation clinics
- Cardiac laboratory technicians
- Cardiology departments
- Cardiology nurses
- Cardiothoracic departments
- Cardiothoracic surgeons
- Clinical perfusionists
- Community hospitals
- Community nurses
- Coronary care departments
- Coronary care nurses
- Day surgery units
- District nurses
- EBME departments
- Endocrinology units
- ENT departments
- ENT medical staff
- Equipment stores
- Equipment libraries and stores
- Gastroenterology departments
- Gastro-intestinal surgeons
- General surgeons
- General surgery
- General surgical units, directors of
- Gynaecology departments
- Gynaecology nurses
- Haemodialysis nurses
- Haemodialysis units
- Health and safety managers
- Hospital at home units
- In-house maintenance staff
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- IV nurse specialists
- Maintenance staff
- Minor injury units
- Maternity units
- Maxillofacial departments
- Medical directors
- Medical libraries
- Medical oncologists
- Neonatal nurse specialists
- Neonatology departments
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Obstetrics departments
- Obstetrics nurses
- Oncology nurse specialists
- Operating department practitioners
- Oral surgeons
- Orthopaedic surgeons
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric intensive care units
- Paediatric nurse specialists
- Paediatric oncologists
- Paediatric surgeons
- Paediatric surgery, directors of
- Paediatric wards
- Paediatrics departments
- Palliative care teams
- Patient transport managers
- Peritoneal dialysis units
- Purchasing managers
- Renal medicine departments
- Renal medicine, directors of
- Risk managers
- Special care baby units
- Supplies managers
- Theatre managers
- Theatre nurses
- Urological surgeons
- Urology departments
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
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/2018/006 or 2017/006/013/291/012.
Ruth Lloyd-Williams or Enitan Taiwo, MHRA
Tel: 020 3080 6972 / 7122
firstname.lastname@example.org or email@example.com
Devices Clinical Team, 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, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Northern Ireland Adverse Incident Centre (NIAIC)
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).