TSC Life Receives FDA Clearance for Pediatric Use of Fluido® Compact Blood and Fluid Warming System
核心洞察
TSC Life (搜索) announced FDA clearance for pediatric use of its Fluido® Compact (搜索) Fluid Warming System, allowing official marketing to hospitals for pediatric patients in the U.S. and Canada.
The system addresses critical hypothermia (搜索) risks in pediatric surgery, with the device suitable for newborns weighing as little as 7.7 pounds and offering normothermic flow rates starting at 5ml/min.
Clinical evidence demonstrates that one unit of refrigerated blood or one-liter crystalloid at room temperature can reduce mean body temperature by 0.25°C, reinforcing the need for active fluid warming.
TSC Life (搜索), a Netherlands-based medtech company, announced that the U.S. Food and Drug Administration has cleared its Fluido® Compact (搜索) Fluid Warming System for pediatric use. The pediatric indication enables TSC Life to officially market the system to hospitals specifically for pediatric patients in the United States and Canada.
Addressing Critical Hypothermia Risks in Pediatric Surgery
"The FDA's clearance is a strong recognition of the safety and benefits of this fluid warming system to this vulnerable pediatric population, which are the most critical patients at risk for inadvertent hypothermia (搜索) during surgery," said Chris Duffie, U.S. Commercial VP.
Pediatric patients face unique thermoregulatory challenges during surgical procedures. Even brief surgical procedures can lead to hypothermia (搜索), as body temperature may significantly decrease within 60 minutes of administering anesthesia. The Fluido® Compact (搜索) system can be used for pediatric patients and newborns weighing as little as 7.7 pounds (3.5 kilograms) and above.
Clinical Evidence Supporting Fluid Warming
Over a decade of market adoption and usage in the U.S., Europe and elsewhere have shown the effectiveness of blood and fluid warmers in pediatric care, demonstrating their ability to maintain safe temperatures and reduce the risk of hypothermia (搜索). The importance of maintaining normothermia during surgery to prevent complications such as surgical site infections (搜索) (SSI), coagulopathy (搜索), and adverse cardiac events has been well documented.
Clinical guidelines reinforce the critical need for warm fluids: One unit of refrigerated blood or one-liter crystalloid at room temperature can reduce mean body temperature by 0.25°C. Fluid warming is the only method that produces direct core warming and is recommended for all intraoperative infusions ≥ 500mL in adults.
The Association of periOperative Registered Nurses (AORN (搜索)) updated its guideline in 2025 on effective patient temperature management. AORN's guidelines "reinforces the importance of active warming methods, such as forced-air warming, over passive insulation. Research demonstrates that active warming is more effective in raising patient temperature and preventing hypothermia (搜索), especially during general anesthesia."
System Design and Clinical Applications
The Fluido® Compact (搜索) is designed to accompany patients throughout their entire care journey—from the Emergency Department to the Operating Room and into Recovery. The system offers easy setup, operation and maintenance, low priming volume, portability within the hospital, and normothermic flow rates starting as low as 5ml/min.
TSC Life (搜索) describes the device as "a uniquely suited solution for hospitals and clinics looking for a low flow blood and fluid warmer for pediatric and adult use." The system has been on the market in Europe and many parts of the world for more than 10 years, with a global installation base in excess of 10,000 units.
Commercial Strategy and Market Expansion
In early 2025, TSC Life (搜索) transitioned from relying on Stryker to distribute its Mistral-Air® forced air blanket warming portfolio to building its own direct commercial team in the U.S. market. This shift has accelerated company expansion, strengthened customer relationships, improved U.S. customer care, and opened the door for product introductions like Fluido® Compact (搜索) to the U.S. market.
TSC Life (搜索) has more than 30 years of experience in developing, manufacturing, and delivering healthcare solutions to hospitals and care facilities worldwide. The company's portfolio includes Mistral-Air® forced air warming systems, Fluido® blood and fluid warming systems, and Broncoflex® single-use bronchoscopes.