B. Braun Receives FDA Clearance for Infusomat® Space Pump
B. Braun receives FDA clearance for Infusomat® Space Pump
BETHLEHEM, PA – September 22, 2015 – B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, announced today that it has received 510(k) clearance for its second-generation, large-volume Infusomat® Space Pump.
The Infusomat Space Pump is intended for adult, pediatric and neonatal patients for the delivery of parenteral fluids, medications, blood and blood products delivered through intravenous, intra-arterial, subcutaneous, and epidural routes of administration. Its compact and intuitive design allows for flexibility and easy transport within a healthcare facility, promoting efficiencies in hospital or outpatient settings.
B.Braun collaborated with Healthcare Human Factors, one of the largest teams dedicated to healthcare human factors in the world, to conduct usability testing on the Infusomat Space Pump. “Clinicians, including nurses and anesthesiologists, participated in extensive software navigation testing,” said Mike Golebiowski, Vice President of Marketing, Automation and Infusion Systems at B.Braun. “Based on their feedback, we optimized the pump’s user interface to enhance efficiencies and make programming easy and intuitive.”
“One unique feature that is only available in the second-generation Infusomat Space Pump is the healthcare worker’s ability to change care units without having to stop or reprogram the infusion,” he said. “This represents an important advance in maintaining drug library compliance.”
Key features of the pump include:
- Easy, vertical stacking for increased versatility and space savings.
- Independent modularity in each pump to help prevent channel confusion and potential pump failures.
- Real-time wireless reporting with B.Braun’s DoseTrac® Infusion Management Software.
- Wireless EMR integration with B.Braun’s AutoCOMPLETE™ Integrated EMR, which includes auto-programming, auto-documentation and auto-notification (alerts).
- Non-numeric keypad using arrows to help prevent manual programming errors related to zero versus decimal entry.
- Intuitive user interface with safety prompts and pictograms to support practice.
- Extensive drug library with customizable hard and soft limits and clinical advisories.
“With the goal of improving patient outcomes, the second-generation Infusomat Space Pump integrated with DoseTrac and AutoCOMPLETE are the building blocks for B.Braun’s Synchronized Intelligence Infusion Platform™,” Golebiowski said. “The pump is the first step to a wireless, integrated technology system that ultimately can help clinicians achieve 100% drug library compliance, minimize medication errors and reduce alarm alerts.”
Learn more about B.Braun’s Infusomat Space Pump and Synchronized Intelligence Infusion Platform click here.
About B. Braun
B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. The Company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. Guided by its “Sharing Expertise®” philosophy, B.Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.
The B.Braun Group of Companies in the U.S. includes B.Braun, B.Braun Interventional Systems, Aesculap® and CAPS®. B.Braun’s U.S. headquarters is located in Bethlehem, Pennsylvania. The B.Braun Group of Companies employs more than 54,000 employees in more than 60 countries throughout the world. To learn more about B.Braun visit www.BBraunUSA.com