BD 3rd Edition T34™ Ambulatory Syringe Pumps (ICN 1206)
Important Customer Notice Field Safety Notice
- BD has issued a Field Safety Notice to advise of an update being made to the Directions for Use (DFU) for the 3rd Edition T34™ Ambulatory Syringe Pumps.
- If the T34™ 3rd Edition Ambulatory Syringe Pump is stored without the main 9V battery for several days or weeks, it may result in partial or full depletion of the 3V internal battery.
- The 3V battery powers the internal real-time clock. The 3V depletion may trigger two different issues: “Timer’s battery fail” alarm and real-time clock time lag/delay.
- The T34 syringe driver pump is available from NHS Supply Chain via our eDirect route, with a bespoke NPC created for each trust as required.
- 2nd Edition T34™ pumps are not affected as they do not contain a 3V rechargeable battery but a non-rechargeable battery instead.
- Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products. See our Downloads ▼ section
- Please complete the Customer Acknowledgement Form (Page 3) and return the completed form to BD at T34FieldAction@bd.com no later than 5 March 2021.
- Append Attachment 1 of this Field Safety Notice to your current Directions for Use (DFU999-103EN Rev. 04) for the 3rd Edition T34™ Ambulatory Syringe Pumps in your possession.
- Syringe Pump and Unpacking – Verify that the date and time are accurate before starting the infusion by checking the last entry in the event log. If the date and time are not correct, adjust the date and time per Section 5.6 of the DFU (Practice Scenarios for Changing Pump Configuration).
- Pump Storage – If the pump is stored without a 9V battery verify the date and time are accurate before starting the infusion by checking the last entry in the event log. In the case, date and time is not correct, please adjust date and time accordingly.
- Should you have any questions or experience any issues associated with the product or issue described in this Field Safety Notice, please contact T34FieldAction@bd.com.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor