Mains power lead used with Omnifuse syringe pumps (part number 0151-0651) - quarantine affected leads

(Smiths Medical International Ltd. - all models) incorrect design of the mains lead causes a risk of interruption or delay in therapy. (MDA/2014/044)

CAS deadlines
Action underway:  10 December 2014, action complete:   24 December 2014  

Note: These deadlines are for systems to be in place to identify affected leads and to contact the manufacturer for a replacement.

Device

Medical Device Alert: Mains power lead used with Omnifuse syringe pumps (all models).Part number 0151-0651. Manufactured by Smiths Medical International Ltd. (MDA/2014/044)

Mains power lead used with Omnifuse syringe pumps (all models).
Part number 0151-0651.
Manufactured by Smiths Medical International Ltd.

Problem

Risk of interruption or delay in therapy due to incorrect design of the mains lead supplied by Smiths Medical.

Smiths Medical Ltd has issued a Field Safety Notice (FSN), dated November 2014, to its customers recalling affected products but hasn’t had enough replies to know that users have received and acted on this information.

The original FSN was sent in September 2014.  The manufacturer recently identified that more customers were affected and so has issued this second FSN. These 2 FSNs provide the same information.

Action

  • Ensure all personnel using these devices are aware of this FSN.
  • Quarantine affected leads.
  • Use an alternative pump, where available until a replacement lead is obtained.
  • Fill in the confirmation form in the FSN and return it to the manufacturer by fax on 01582 430 001 or by  email to ukcs@smiths-medical.com

Action by

All staff responsible for the use, maintenance and purchase of these devices.

Distribution

This MDA has been sent to:

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

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment.

Below is a suggested list of recipients.  

Trusts

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

  • A&E departments
  • A&E directors
  • Adult intensive care units
  • All departments
  • All wards
  • Biomedical engineering staff
  • Clinical governance leads
  • EBME departments
  • Equipment stores
  • General surgery
  • General surgical units, directors of
  • Health and safety managers
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care, directors of
  • IV nurse specialists
  • Maintenance staff
  • Medical directors
  • Medical libraries
  • Medical oncologists
  • Medical oncology, directors of
  • Medical physics departments
  • Midwifery departments
  • Nursing executive directors
  • Outpatient clinics
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Paediatrics departments
  • Patient transport managers
  • Pharmacists
  • Purchasing managers
  • Risk manager
  • Safety officers
  • Supplies managers
  • Theatre managers

Independent distribution

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

This alert should be read by:

  • Clinics
  • Hospices
  • Hospitals in the independent sector
  • Independent treatment centres
  • Private medical practitioners

Manufacturer contact

Smiths Medical International Ltd
George Wiechert
Manager, Quality Systems

Tel:01582 430 330
Fax:  01582 430 001
Email: george.wiechert@smiths-medical.com

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2014/044 or 2014/009/004/121/003

Technical aspects
Enitan Taiwo / Patrick Sweeney
Medicines and Healthcare Products Regulatory Agency
Floor 4,
151 Buckingham Palace Road
London SW1W 9SZ
Tel:020 3080 7122 / 6898 Fax:020 8754 3965

Email: enitan.taiwo@mhra.gsi.gov.uk
patrick.sweeney@mhra.gsi.gov.uk

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

Email:mark.grumbridge@mhra.gsi.gov.uk

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

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

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 

Scotland

All requests regarding return, replacement or modification of the devices mentioned in this alert should be directed to the relevant supplier or manufacturer.

Other 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

Email: nss.iric@nhs.net

Incident Reporting and Investigation Centre 

Wales

Enquiries in Wales should be addressed to:

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

Email: improvingpatientsafety@wales.gsi.gov.uk

Download documents

Medical Device Alert: Mains power lead used with Omnifuse syringe pumps (all models).Part number 0151-0651. Manufactured by Smiths Medical International Ltd. (MDA/2014/044) (308Kb)

Help us improve GOV.UK

Don’t include personal or financial information, eg your National Insurance number or credit card details.