Field Safety Notice Baxter Braun 6000 Instructions for Use Update (ICN 2689)

Alert:

• NHS Supply Chain has been made aware of two Field Safety Notices issued by Baxter on 26 June 2024 and 26 September 2024, due to Baxter identifying that the Braun Thermoscan Pro 6000 ear thermometers issued between 15 September 2022 and 22 February 2024 were supplied with a compact disc (CD) containing an outdated version of the instructions for use (IFU).
• The current, correct instructions for use include an additional warning regarding proper cleaning and the risks associated with the speculum tip potentially overheating due to fluid ingress.
• If the correct cleaning instructions are not followed the device may be exposed to fluid ingress. If this occurs there is a risk of the probe tip over heating and potentially causing a burn to the user, or to the ear canal of the patient.
• In addition, fluid ingress may cause inaccurate temperature readings.

Products Affected:

•  The two products affected are available from NHS Supply Chain:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• The material number is printed on the CD.
• Clinicians may continue to use the Pro 6000 ear thermometers according to the current IFU, CD material number
• Please discard all versions of the outdated IFU, CD material number 419450.
• The correct version of the IFU can be found on the Hillrom website, by accessing the Braun ThermoScan Pro 6000 (R) products page.
• From the home page, choose Products – Physical Exam & Diagnostics – Thermometry, then scroll down to the pictured results and click on Braun ThermoScan PRO 6000 (R); or use the following link: Welch Allyn Braun ThermoScan PRO 6000 Ear Thermometer
• The IFU can be found in the ‘Education and Documentation’ section, under ‘User Manual’.
• Complete and return attachment one, ‘Customer Reply Form’, page four of the FSN to: uk_shs_fca@baxter.com
• If users require any updated training or need any further information please do not hesitate to contact: hollie_thackway@baxter.com or kelly_woodcock@baxter.com

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice / Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.