Omnifuse and Omnifuse PCA Syringe Pumps

Notice type: Advisory

Date: 07/02/2012


Product name or type:
Omnifuse and Omnifuse PCA Syringe Pumps


Manufacturer Or Supplier:
Smiths Medical International

Target Audience:
Hospital CEOs 
Hospital Risk Managers 
Medical Nursing Staff 
Palliative Care Units 
Intensive Care Units 
Anaesthetic Officers 
General Practitioners 
Practice Nurses 
Clinical Engineers 
General Public 
Nursing Homes 
Community Care Managers 
Community Therapists 

Problem Or Issue:
The Omnifuse and Omnifuse PCA Pumps may alarm and stop delivery of infusion due to significant vibration when transporting the pumps.

Background Information Or Related Documents:
In July 2011, Smiths Medical initiated a field safety corrective action to highlight the possible impact of significant vibration or jarring to Omnifuse and Omnifuse PCA Pumps in inducing a System Fault Code, causing the Pump to alarm and stop delivery of the infusion. This is due to the sensitivities of the precision accuracy detection mechanisms within the Omnifuse Pumps. 

An example of the type of vibration or jarring that may induce a System Fault Code would be transporting a pump across an uneven surface (e.g., block paving). Smiths Medical has outlined recommendations for users of these devices to avoid this system error from occurring. The field safety notice associated with this issue is attached with this safety notice. 

The manufacturer has notified the Irish Medicines Board (IMB) that despite their best efforts they have not managed to receive 100% reconciliation for acknowledgements of receipt of the field safety notice from customers in the Irish market. The IMB is issuing this safety notice to ensure all users of these devices are aware of this issue and to request that customers, upon receipt of the field safety notice, will confirm with the manufacturer that they are aware of the issue. 

Omnifuse and Omnifuse PCA Syringe Pumps Document

Actions To Be Taken:
1. Ensure that the relevant personnel in your organisation are made aware of this issue. 

2. Follow the recommendations as outlined by the manufacturer in the field 
safety notice attached and confirm acknowledgement of receipt of the field 
safety notice to the manufacturer. 

3. If you have any concerns or queries relating to this issue please contact the 
manufacturer using the contact details below.

Further Information:
All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 

Enquiries to the manufacturer should be addressed to: 


Smiths Medical International Ltd

Bramingham Business Park, 
Enterprise Way, 
LU3 4BU, 
United Kingdom. 

Telephone: +44 (0)1582 430307 ext. 4770307 

Please click here to download a PDF version of this Safety Notice

Please click here to download a PDF version of the field safety notice

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