Correction of Infusion Pumps: A Close Look at B. Braun Medical Infusomat Space Systems7

This recall pertains to adjustments required for specific devices, rather than their removal from use or sale. The FDA has classified this as the highest level of recall. Continued use without remedy may lead to severe injury or even fatality.

Products Involved

• Product Names: lnfusomat Space Infusion System/Large Volume Pump, Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK

Recommended Actions

• Avoid using affected devices for administering high-risk medications. 

On August 6, 2024, B. Braun Medical Inc. dispatched an Urgent Medical Device Correction letter to all concerned customers advising the following measures: 

Interim Measures for Users

• Utilize alternate devices that fall outside the specified serial number range for high-risk medication delivery.
• Store affected devices in areas where high-risk medications are not administered until the occlusion sensor is replaced.

If it becomes necessary to utilize affected pumps for delivering high-risk medications beforehand:

• Keep a backup pump available when feasible.
• Increased monitoring might be necessary.
• If frequent false occlusion alarms occur, power off the device for 48 hours. Ensure the device is kept in an area without high-risk medication use and closely monitor it.
• For technical support if the above actions cannot be implemented, reach out to B. Braun Medical Inc. at 1-800-627-7867 (1-800-627-PUMP). 

B. Braun Medical Inc. is organizing the update of impacted devices; the following steps may assist in the continued operation of the pumps.

Customer Action Steps

• Review the notification. 
• Inform all users and relevant personnel regarding this voluntary correction.
• Implement appropriate interim measures.
• Identify all devices with affected serial numbers. 
• Utilize stickers from the letter to aid clinical and biomedical engineering staff in identifying impacted devices.
• Document the total count of affected units using the Product Correction Acknowledgement Form attached to the letter. 
• Return the completed Product Correction Acknowledgement Form to B. Braun Medical Inc.’s Quality Assurance department via fax at (610) 849-1197 or email at PA_QualityAssurance.BBMUS_Service@bbraunusa.com within a fortnight, even if no affected devices are in stock. 
  • A Field Service Representative will reach out to customers to set a time and date to check affected pumps and replace sensors after the acknowledgement form is submitted. 
• Distributors should pass this notification along to their clients. 

Reason for Adjustment

B. Braun Medical Inc. is broadening a previous recall to include the lnfusomat Space Infusion System/Large Volume Pump along with the previously listed models, Infusomat Space Large Volume Pump Wireless and Infusomat Space Large Volume Pump Non-Wireless BATTERY PACK, due to the risk of false occlusion alarms which may halt the delivery of crucial high-risk medications, like vasopressors that are vital for stabilizing blood pressure.

Utilization of affected devices poses serious health risks, including unstable blood pressure and possible fatal outcomes. 

One injury and one fatality have been reported in connection to this issue. 

Device Functionality

Infusomat Space Infusion Pump systems are utilized by duly trained medical professionals within healthcare facilities. These pumps serve adults and pediatric patients (including neonates, infants, children, and adolescents) for the intermittent or continuous administration of fluids, medications, and blood products.

Contact Details

U.S. customers with inquiries about this recall should reach out to B. Braun Medical Inc. Postmarket Surveillance Department at 1-833-425-1464.

Further FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) system is designed to trace individual medical devices marketed in the United States from their manufacture through to their patient use. This system facilitates improved accuracy in reporting and analyzing adverse events, allowing for quicker identification and rectification of related issues.

Reporting Issues

Healthcare professionals and consumers may report adverse reactions or quality issues associated with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.