GemStar docking station for use with specific GemStar infusion pumps - potential for delay in infusion therapy

(Hospira) May fail to power up or configuration could generate an error code, stopping a running infusion. (MDA/2013/085)

CAS deadlines

Action underway: 2 January 2014, action complete: 30 January 2014
Note: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up.


GemStar docking station

GemStar docking station for use with specific GemStar infusion pumps.

Manufactured by Hospira.

The specific products potentially affected by the two problems are shown below:

Affected product (docking station list numbers) Issue Potential to occur in conjunction with products
13075-XX-07, 13075-XX-09 Pump fails to power up Gemstar phase 3 pump (13000-XX, 13100-XX, 13150-XX)
13075-XX-07, 13075-XX-09 Error code 11/003 on pump and infusion stops Gemstar phase 4 pump (13086-XX, 13087-XX, 13088-XX)
13075-XX-07, 13075-XX-09 Error code 11/003 on pump and infusion stops External battery pack (13073-XX)

If you are unsure whether the Gemstar infusion pump is a phase 3 or a phase 4 contact Hospira for clarification.

There is no corrective action in place to resolve this issue. Hospira is offering the Sapphire pump, manufactured by Q Care, on a part exchange basis to replace Gemstar pumps as detailed in Medical Device Alert MDA/2013/078.


Potential for a delay in infusion therapy.

Two problems exist:

  • when the docking station is used in conjunction with a Gemstar phase 3 infusion pump, the pump may fail to power up
  • when the Gemstar phase 4 infusion pump is used in conjunction with both a docking station and an external battery accessory, this configuration could generate an error code 11/003, which could stop a running infusion.

The manufacturer issued a Field Safety Notice (FSN) dated 24 October 2013 (570Kb) but has not received sufficient confirmation that it has been received and acted upon.


Identify affected devices/device combinations.

Use an alternative pump, where available.

Be aware of the recommendations in MDA/2013/078.

If an alternative is not available:

  • assess the risks and benefits of using these pumps for each individual patient
  • ensure that staff are aware of all the issues and actions to be taken as specified in the manufacturer’s Field Safety Notice
  • exercise caution in use
  • report any adverse incidents involving these devices to the MHRA.
  • fill in and return the reply form to Hospira.

Action by

All medical, nursing and technical staff involved in the use of these devices.


This MDA has been sent to:

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • NHS England area teams for information
  • NHS trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • A&E consultants
  • A&E departments
  • A&E directors
  • A&E nurses
  • Adult and Paediatric intensive care units
  • All staff
  • All wards
  • Anaesthesia, directors of
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Biomedical engineering staff
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Cardiothoracic departments
  • Clinical governance leads
  • Clinical perfusionists
  • Community children’s nurses 
  • Community hospitals
  • Coronary care departments
  • Coronary care nurses
  • Day surgery units
  • District nurses
  • EBME departments
  •  Endocrinology units
  • Endocrinology, directors of
  • ENT departments
  • ENT medical staff
  • ENT services, directors of
  • Equipment stores
  •  Equipment libraries and stores
  • Gastroenterology departments
  • Gastroenterology, directors of
  • General surgery
  • General surgical units, directors of
  • Gynaecologists
  • Gynaecology departments
  • Gynaecology nurses
  • Haemodialysis nurses
  • Haemodialysis units
  • Hospital at home units
  • In-house maintenance staff
  • IV nurse specialists
  •  Maintenance staff
  • Maternity units
  • Medical physics departments
  • Midwifery departments
  • Midwifery staff
  • Obstetrics and gynaecology departments
  • Obstetrics departments
  • Obstetrics nurses
  • Oncology nurse specialists
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Paediatric oncologists
  • Paediatric surgeons
  • Paediatric surgery, directors of
  • Palliative care teams
  • Peritoneal dialysis units
  • Purchasing managers
  • Renal medicine departments
  • Renal medicine, directors of
  • Risk managers
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only) optional

This alert should be read by:  

  • 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: and requesting this facility.

Manufacturer contact

Manufacturer’s authorised representative

John McIlvaney
Customer Services Manager
Hospira UK
Royal Leamington Spa

Tel: 0800 028 7304



If you have any comments or feedback on this Medical Device Alert please email us


If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/085 or 2013/010/024/291/010.

Technical aspects

Yasser Zayni or Ian Sealey
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7238 or 6691
Fax: 020 8754 3965

Email: or

Clinical aspects

Mark Grumbridge
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7128
Fax: 020 8754 3965


How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website 

Northern Ireland

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900


How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS website


Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722



Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922


Download documents

Medical Device Alert: GemStar docking station for use with specific GemStar infusion pumps manufactured by Hospira (MDA/2013/085) (209Kb)

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