Life Warmer Quantum Blood and Fluid Warming System
NORTH AMERICAN RESCUE, LLC · Model 63-5900 · UDI-DI 00868058000485
Description
The Lifewarmer Quantum Blood and Fluid Warming System 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 TTS-B (Thermal Transfusion Set - Blood) NOTE: TTS-B is Single Use Only, Supplied sterile via Ethylene Oxide
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | ICU Medical Inc. | ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing t |
| 2025-04-22 | 3M Company | Notice was issued to clarify flow rates related to the inlet fluid temperature. |
| 2025-03-31 | Belmont Instrument LLC | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. |
| 2025-03-31 | Belmont Instrument LLC | Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser. |
| 2025-03-31 | Belmont Instrument LLC | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. |
| 2025-03-31 | Belmont Instrument LLC | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. |
| 2021-08-06 | Smiths Medical ASD Inc. | There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. |
| 2021-08-06 | Smiths Medical ASD Inc. | There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. |
| 2021-06-04 | Eight Medical International BV | The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions. |
| 2021-04-30 | RanD S.r.l. | The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots |
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