The 3M Company has announced a critical correction for its Ranger Blood and Fluid Warming Systems, following discrepancies between labeled performance and actual device capabilities. This update is essential for healthcare professionals and regulatory teams handling these medical devices in clinical settings.
Which products are affected?
The affected products include:
- 3M Ranger Blood/Fluid Warming High Flow Sets: Catalog Numbers 24355 and 24370 used with Model 245 warming unit.
- 3M Ranger Fluid Warming Irrigation Set: Catalog Number 24750 used with Model 247 irrigation warming unit.
These devices are used to warm blood, blood products, and irrigation fluids to temperatures between 33°C and 41°C, helping to prevent complications like hypothermia during medical procedures. The systems are intended for use by trained medical professionals in clinical environments.
What changed?
On April 21, 3M issued an Urgent Medical Device Correction to customers after testing uncovered discrepancies in performance at high flow rates. The existing label of the Ranger Blood and Fluid Warming System suggests it can maintain output temperatures of 33°C to 41°C at flow rates up to 500 mL/min. However, testing revealed limitations in its warming capacity:
- At inlet temperatures of 20°C (ambient), the system effectively warms fluids at flow rates up to 333 mL/min.
- At lower inlet temperatures of 4°C, optimal warming occurs at flow rates up to 167 mL/min.
If the device is operated outside these updated flow rate parameters, there is a risk of administering fluids below the required temperature, leading to potential adverse health consequences such as hypothermia. While no injuries or deaths have been reported to date, healthcare facilities must adhere to the updated instructions provided by 3M.
What actions should you take?
3M recommends the following steps:
- Ensure this correction notice is shared with all relevant personnel within your organization.
- Update operating procedures to reflect the corrected labeling, including instructions on temperature measurement and flow rate limits.
- Continue using the affected devices in compliance with the revised guidelines.
- Retain this notice until updated instructions for use (IFUs) and operator manuals are made available.
- Complete and return the attached customer acknowledgment form.
For questions, U.S.-based customers can contact the 3M Customer Helpline at 1-800-228-3957, option 6.
What are the safety implications?
The identified issue presents a critical risk regarding fluid temperatures during administration, particularly in scenarios requiring high flow rates. In such cases, improperly warmed fluids may result in hypothermia, which can lead to severe complications or even death.
The FDA has classified this recall as the most serious type due to the potential for harm if the updated instructions are not followed. It highlights the importance of compliance with manufacturer guidelines to ensure patient safety and device efficacy.
Conclusion
Healthcare providers should prioritize the dissemination of this information and implement necessary operational changes immediately. While the devices remain functional under revised parameters, ensuring adherence to the newly issued guidelines is essential to mitigating risks and safeguarding patient outcomes.
Disclaimer
This content is provided for educational and informational purposes for professionals. It does not constitute legal or regulatory advice. For specific compliance requirements, consult the FDA or your organization’s regulatory authority.
Mandatory FDA Disclosure
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/blood-and-plasma-warming-device-correction-3m-company-issues-correction-ranger-bloodfluid-warming