- Ensure that systems are in place to make relevant users aware of the problem and the updated advice detailed in the manufacturer’s field safety notice (FSN).
- Ensure that a copy of the ‘Addendum’ included in the FSN is added to local copies of the Sapphire infusion pump user manual
- Complete and return the customer response form to Q Core.
- All healthcare workers who use these devices.
Deadlines for actions
Actions underway: 9 December 2015, actions complete: 18 January 2016
Sapphire multi-therapy pump – Hospira L/N 163116501 and 163113601 or Q Core P/N 15031-000-0001
Sapphire epidural pump – Hospira L/N 163126501 and 163123601 or Q Core P/N 15032-000-0001
Fluctuations in flow rate accuracy caused by a number of factors, including the size of the epidural catheter used.
Telephone: 00 972 73 238 8888
Hospira Global Complaint Management
Telephone: 0800 0287 304
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
- all departments
- all wards
- ambulance services directors
- ambulance staff
- anaesthesia, directors of
- anaesthetic medical staff
- community midwives
- general surgery
- hospital at home units
- intensive care medical staff/paediatrics
- intensive care, directors of
- maternity units
- midwifery departments
- midwifery staff
- obstetrics and gynaecology directors
- obstetrics departments
- obstetrics nurses
- pain clinics
- pain management teams
- palliative care teams
- resuscitation officers and trainers
- risk managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- 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: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/037 or 2014/012/005/401/003.
Roopa Prabhakar or Jenifer Hannon, MHRA
Telephone: 020 3080 7293 / 7153
Dr S Jagdish
Telephone: 020 3080 7187
Reporting adverse incidents in England
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
Telephone: 028 9052 3868
Fax: 028 9052 3900
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
Telephone: 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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 02920 823 624/02920 825 510