Field Safety Notice issued for B. Braun Infusomat Space and Perfusor Space pumps

Last Updated on 02/11/2026 by Sarah Sarsby

BHTA member B. Braun has issued a Field Safety Notice concerning known software-related conditions that may interrupt infusion therapy in Infusomat Space, Infusomat Space P, and Perfusor Space devices operating with software versions prior to N09.

The notice provides safety information and confirms that software versions prior to N09 are no longer supported for software maintenance. It is not a product recall and does not require device removal or a mandatory software update.

What has been identified?

Under specific operating circumstances, known software-related conditions may cause device alarms and interrupt infusion delivery, unrelated to user handling. When an alarm occurs, infusion delivery stops and audible and optical signals alert the user.

B. Braun states that the alarms for Infusomat Space and Perfusor Space devices are identical to those described in the instructions for use and should be handled in the same way.

What is the potential risk?

Temporary interruption of infusion therapy may be clinically relevant depending on the patient’s condition, medication, infusion rate, and clinical setting. In certain circumstances, prolonged interruption could lead to serious patient harm if appropriate clinical intervention is not performed.

B. Braun states that available post-market and risk assessment information indicates that serious outcomes remain unlikely, and that the overall residual risk related to software conditions remains acceptable and is continually monitored.

If life-saving medication is being administered, users must, in accordance with the instructions for use, ensure supplemental patient monitoring and have a second infusion pump immediately available for the relevant drug.

Support for older software versions

B. Braun has discontinued software maintenance support for versions prior to N09. These versions will no longer receive software updates, patches, or technical software support for software maintenance purposes.

General device service, complaint handling, vigilance reporting, and safety-related investigations remain available.

Software versions currently available on the market remain acceptable for continued use. B. Braun recommends implementing N09 where feasible.

What should suppliers and distributors do?

The information should be shared with all relevant departments, including clinical, technical, and biomedical personnel, as well as distribution partners.

Where products have been distributed to a third party, recipients should forward a copy of the information or inform B. Braun’s contact person identified in the notice.

Recipients are asked to complete and return the feedback form to Catherine Clulow at recalls.uk@bbraun.com. For acknowledgement enquiries, she can be contacted on 0114 2259155. The form requests confirmation that the notice has been received and a copy sent to all affected customers.

What should users and healthcare institutions do?

Users should review and document installed software versions in accordance with their organisation’s maintenance and quality procedures, and ensure appropriate local awareness of alarm response actions.

Healthcare institutions should evaluate N09 implementation against their clinical use cases, device configurations, enabled software functions, and local risk management procedures. Users should also assess local maintenance, validation, training, and workflow requirements.

N09 has been released and distributed since July 2025 and provides corrections for known root causes, improvements, new features, and ongoing software support. Information on obtaining and implementing it is available from the responsible B. Braun Service.

Further information

For technical information, contact Andrew Bodman, Technical Customer Support Manager, at andrew.bodman@bbraun.com or on 07977 248089.