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Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units

Notice type: Recall

Date: 08/04/2011

  

Product name or type:
Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units

Reference:
IMB Safety Notice: SN2011(05)

Manufacturer Or Supplier:
Smiths Medical

Target Audience:
All Hospital Staff 
Emergency Departments 
Intensive Care Units 
Cardio Thoracic Units 
Clinical Perfusionists 
Theatre Managers 
Theatre Nurses 
IV Nurse Specialists 
Risk Managers 
Central Sterile Supply Department (CSSD) Personnel 
Clinical / Biomedical Engineering 
Purchasing Managers

Problem Or Issue:
Smiths Medical has become aware of an increased trend in reports of kinking of the tubing on certain Level 1® Normothermic IV Fluid Administration Sets (Models DI-65HL, DI-75 and DI-150). In some cases, the kink may lead to a decrease in the flow of fluid to the patient. A reduction in flow rate may lead to a delay of therapy, which could result in patient injury.

Background Information Or Related Documents:
Smiths Medical has ceased production and supply of the affected devices and has initiated a removal of affected devices from the market. To prevent recurrence of this kinking issue, Smiths Medical will implement a design change on the affected sets. As outlined in the attached field safety notice, Smiths Medical will supply alternative replacement sets pending availability of the new product. 
Users should note that these alternative replacement sets are not equipped with the F-50 Gas Vent Filter Assembly and there is a risk of air embolism with the device if the power supply to the fluid warmer unit is interrupted during an air detection alarm e.g. by manually switching off the power during an air detection event. Smiths Medical issued a quick reference guide in 2007 to notify users of this air embolism issue. Refer to the attached IMB Safety Notice SN2008(2) for additional information on the quick reference guide.

Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units Document

Actions To Be Taken:
The Irish Medicines Board advises users of this product to inspect their inventory and segregate the affected products for return to the manufacturer as per the attached field safety notice. 
Users should exercise extreme caution when using the alternative replacement products and remain cognisant of the clinical risks associated with these sets, which are not equipped with the F-50 Gas Vent Filter Assembly. 

Users should also take care to: 

• Ensure that all Level 1® fast flow fluid warmer units contain a copy of the quick reference guide distributed by Smiths Medical in 2007. 
• Contact the manufacturer to request a copy of the quick reference guide if required.

Further Information:
Enquiries to the manufacturer / European authorised representative should be addressed to: 
Mr. Franz Korner 
Smiths Medical 
Bretonischer Ring 3 
Grasbrunn 
D-85630 
Germany 

Tel: +49 89 242959 345 
Fax: +49 89 242959 327 
E-mail: eu.rep@smiths-medical.com 

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 
E-mail: vigilance@imb.ie
Website: www.hpra.ie

Please click here to download a pdf version of the Safety Notice SN201105

Please click here to download a pdf version of the Field Safety Notice SN201105

Please click here to download a pdf version of the Safety Notice SN200802

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