Field Safety Notice Smiths Medical Fluid Warming Normo-Thermic Irrigation Sets (ICN 1554)

Recall Ref: 69

Alert:      

• Smiths Medical has initiated a voluntary Field Safety Correction Action (FSCA) for Fast Flow Fluid Warming and irrigation System devices due to the potential for aluminium ion leaching into warmed fluids.
• Aluminium ion leaching has been identified in the disposable sets used within these systems.
• Please see our Downloads ▼ section to view the Medical Device Field Safety Notice: Level 1® Fluid.
• The Notified Body reviewed the Affected Product Models of level 1 Fast Flow Fluid Warming and Irrigation System devices listed on page 1 and has suspended the CE mark for the affected devices until further notice.

Products Affected:

• Ten of these products were available from NHS Supply Chain’s eDirect or Blue Diamond route. Please refer to the attachment for full details.

Next Steps:

• Note although alternatives are available, this is not a like for like product switch as this would require a system wide switch to cover the equipment and associated consumables.
• All customers who purchased Affected Product Models listed in the table on page 1 of the notice must identify any of these products within their possession and refer to the detailed information below:
• Temporarily discontinue use of the Affected Product Models. Affected devices are on distribution hold for the UK until further notice.
• Users of Affected Product Models should seek out alternative devices where available. For hospitals without alternative devices immediately available, an assessment on the use of Smiths Medical’s affected products should be limited primarily to the most urgent cases.
• In urgent cases where no replacement devices are available, and only for patients requiring ongoing therapy at slower flow rates, Level 1® HOTLINE® products may be considered. Note, however, that these are not high flow devices and that the products subject to this FSCA are typically used in acute settings where high volumes of warmed fluids and blood are administered for clinical situations such as: trauma, post-partum haemorrhage and transplant.
• Healthcare facilities can report issues arising from device availability or any of the implementation actions requested in this Field Safety Notice (FSN) to Smiths Medical via:  fieldactions@smiths-medical.com.
• Locate all Affected Devices in your possession and ensure all users or potential users of these devices are immediately made aware of this notification.
• Complete and return the attached Response Form for the Updated Notice to OUS-Smiths@Sedgwick.com.   to acknowledge your receipt and understanding of this Updated Field Safety Notice within 10 days of receipt.
• Adverse events or quality problems experienced with the use of this product must be reported to Smiths Medical via globalcomplaints@smiths-medical.com.
• For questions or difficulties encountered regarding this Field Safety Corrective Action contact fieldactions@smiths-medical.com.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.