The action addresses a discrepancy between the device’s labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.
3M Company is correcting its Ranger Blood/Fluid Warming System, a blood and plasma warming device, due to a need for a labeling correction. The current label does not specify the location of the temperature measurement and corresponding flow rate based on inlet temperature.
The Ranger Blood/Fluid Warming System has a discrepancy between its labeled performance and actual capabilities. While the device is labeled to deliver fluids at 500 mL/min while maintaining 33°C-41°C output temperatures, testing revealed the heater cannot adequately warm fluid at high flow rates. The confirmed specifications show the device can only maintain proper warming temperatures at significantly lower flow rates: up to 333 mL/min with 20°C inlet fluid or up to 167 mL/min with 4°C inlet fluid. If the device is used at a flow rate outside of the updated information provided, there is a potential risk for the device to administer the fluids at a lower temperature.
The use of affected product may cause serious adverse health consequences, including hypothermia and death.
On April 21, 3M Company sent an Urgent Medical Device Correction notice to all affected customers with updated instructions. To date, there have been no reported injuries or deaths related to this issue.
The Ranger Blood/Fluid Warming System includes a Model 245 warming unit that attaches to an intravenous pole and is used with sterile, single-use disposable warming sets. It is intended for use by trained medical professionals to warm blood, blood products, and liquids in clinical settings.
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