BD BodyComm™ version 3.3 software used safety warning over a software fault

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (DSI/2025/006). Quoted as issued.

Summary

The BodyComm software currently uses Windows 10. Microsoft is transitioning to Windows 11 from 14 October 2025 which requires an updated cable to connect the pumps to the BodyComm software. These cables may not be available until after the Windows transition date.

The risk

Summary The BodyComm software is used for the servicing and set up of the Bodyguard pumps, Bodyguard-T and T34 syringe drivers. These pumps are used for pain management and other infusion therapies. Windows 10 will no longer by supported by Microsoft from 14th October 2025. An updated cable is therefore required to connect the pumps to BodyComm software, due to the upcoming transition to Windows 11. However, the cables may not be available until after the Windows transition date. This will need effective management to mitigate potential impact to patient treatment.

Advice for healthcare professionals

The BodyComm software is used for the servicing and set up of the Bodyguard pumps, Bodyguard-T and T34 syringe drivers. These pumps are used for pain management and other infusion therapies.

Windows 10 will no longer by supported by Microsoft from 14th October 2025. An updated cable is therefore required to connect the pumps to BodyComm software, due to the upcoming transition to Windows 11. However, the cables may not be available until after the Windows transition date. This will need effective management to mitigate potential impact to patient treatment.

BD have issued a customer letter advising that all impacted customers should take effective action to allow for continuous use of the BD BodyComm 3.3 software.

Identify whether your site uses the BodyComm software for configuration or servicing of BodyGuard pumps, or for BodyGuard-T and T34 syringe drivers (see device details section).

If you do have the BodyComm software, ensure the following is in place:

A plan to manage service and maintenance of pumps and syringe drivers, which are due for servicing during October 2025 and November 2025 to allow sufficient time to receive the new USB-to-serial cable (OKT00037) for use with Windows 11.

Consider updating the service schedule of BodyGuard pumps and BodyGuard-T/T34 syringe drivers to complete servicing prior to Windows 11 updates in your department or;

as an alternative, in collaboration with your IT department, consider retaining access to a Windows 10 PC to ensure continued servicing and setup of BodyGuard pumps, BodyGuard-T and T34 syringe drivers. This PC will not need a live internet connection for BodyComm to be used, but will require the old USB-to-serial 197-100X cable for connection

Should either of the above options not be possible, manual servicing and operation of pumps and syringe drivers remains possible, but is more time consuming.

3.In the event of usage disruption consider if alternative pump options can be used for patients treated in hospital to ease the pressure on the usage of BodyGuard pumps and BodyGuard-T and T34 syringe drivers.

4.BD will contact you once their new USB to Serial communication cable (product code: OKT00037) for use with Windows 11 and associated instructions for use are ready for release. Once received, ensure the new cable is used as per BD guidance and replace the old communication cable.

5.Ensure that the correct cable is used at all times, as the old and new cable are not interchangeable.

Advice for patients

The advice in this DSI is aimed at clinical engineering/EBME/medical physics departments, who are responsible for managing the equipment. If you have any concerns about this advice, contact your healthcare professional for assistance.

Patients or caregivers using this device should follow the advice of the patient’s healthcare professional.

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