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B. Braun's Infusomat Space Pump receives US FDA approval

Bethlehem, PennsylvaniaSaturday, September 26, 2015, 12:30 Hrs  [IST]

B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, has received 510(k) clearance for its second-generation, large-volume Infusomat Space Pump.

The Infusomat Space Pump is intended for adult, paediatric 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 per cent drug library compliance, minimise medication errors and reduce alarm alerts.”

 
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