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Life Warmer Quantum Thermal Infusion Set (TIS)

NORTH AMERICAN RESCUE, LLC · Model 63-5903 · UDI-DI 00868058000409

LGZBSB Prescription
10
510(k) clearances
6,999
Adverse events (48 deaths)
33
Recalls
72
Facilities

Description

The LifeWarmer Quantum Thermal Infusion Set (TIS) is the revolutionary IV tubing set that allows for safe, rapid warming of IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard IV infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard IV tubing, there is almost no additional equipment burden. The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery. The Quantum Life Warmer, fully charged, is able to warm and maintain up to approximately 1700 mL of 20C IV solution to a set point of 100.4F (38 +/- 2C) at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.

Recalls

DateFirmReason
2026-06-24ICU 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
2025-04-223M CompanyNotice was issued to clarify flow rates related to the inlet fluid temperature.
2025-03-31Belmont Instrument LLCPotential 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.
2025-03-31Belmont Instrument LLCPotential 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.
2025-03-31Belmont Instrument LLCPotential 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.
2025-03-31Belmont Instrument LLCPotential 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.
2021-08-06Smiths 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.
2021-08-06Smiths 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.
2021-06-04Eight Medical International BVThe patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
2021-04-30RanD 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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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.