Sapphire multi-therapy and epidural pumps – update to instructions for use

Manufactured by Q Core Medical, distributed in the UK by Hospira – update to instructions for use regarding fluctuations in flow rate accuracy after potential over-infusion of epidural infusions - MDA/2015/037


  • 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.

Actions by

  • All healthcare workers who use these devices.

Deadlines for actions

Actions underway: 9 December 2015, actions complete: 18 January 2016

Device details

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.

Manufacturer contacts


Q Core
Judith Antler

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
  • obstetricians
  • obstetrics and gynaecology directors
  • obstetrics departments
  • obstetrics nurses
  • pain clinics
  • pain management teams
  • palliative care teams
  • paramedics
  • resuscitation officers and trainers
  • risk managers
  • theatres

Independent distribution

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: and requesting this facility.



Send enquiries about this notice to MHRA, quoting reference number MDA/2015/037 or 2014/012/005/401/003.

Technical aspects

Roopa Prabhakar or Jenifer Hannon, MHRA

Telephone: 020 3080 7293 / 7153

Email: or

Clinical aspects

Dr S Jagdish

Telephone: 020 3080 7187


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

Telephone: 028 9052 3868

Fax: 028 9052 3900


Northern Ireland Adverse Incident Centre (NIAIC)

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.

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


Enquiries in Wales should be addressed to:

Healthcare Quality Division
Welsh Government

Telephone: 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).

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Sapphire multi-therapy and epidural pumps – update to instructions for use

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