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Life Warmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration)

NORTH AMERICAN RESCUE, LLC · Model 63-5906 · UDI-DI 00868058000492

BSBLGZ Prescription
10
510(k) clearances
2,225
Adverse events (23 deaths)
2
Recalls
34
Facilities

Description

The Lifewarmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) is a Game-Changing innovation that has succeeded in closing a critical capability gap previously left exposed by other commercial off-the-shelf fluid warmers currently fielded. Size, weight, performance, and ease of use are no longer collective barriers to the delivery of whole blood in far forward and near point of injury (POI) prehospital casualty management. The Quantum exceeds all healthcare and logistical requirements for the delivery of warmed blood or fluids across the defined spectrum of care. The system consists of unique thermal administration sets that incorporate sensing elements with an integrated heating system that does not disrupt the fluid path. With advanced intelligence throughout the system, the lightweight Controller modulates and moderates the energy flow to the integrated heating elements to ensure consistent normothermic fluid delivery to the casualty. The 44V battery is the smallest in category, able to rapidly adjust power distribution based on the temperature and flow rate of the input fluid. This creates a highly efficient system capable of previously unrealized performance optimizations. The Quantum system has an operational weight of just 22 total ounces yet can deliver two units of 39°F Whole Blood (WB) at 100mL/min with an output temperature of 100.4°F (38°+/- 2°C) with only a 24 second warm-up period. The Quantum Blood and Fluid Warming System provides the Tactical Health Care Professional with significant technological overmatch in the fight to eliminate preventable combat death. Quantum System Contents: 1 x Controller 1 x Battery 1 x Battery Charger 2 x TIS (Thermal Infusion Set) NOTE: TIS is Single Use Only, Supplied sterile via Ethylene Oxide and Not Intended for use with Blood and Blood Products

Recalls

DateFirmReason
2025-04-103M CompanyField action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
2014-07-25Estill Medical Technologies, IncEstill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Ba

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.