3M¿ Ranger¿ Blood/Fluid Warming High Flow Set
Received Jul 27, 2026 · Event occurred Jun 26, 2026
Report 2110898-2026-00056 · MDR key 50046171
Device
Generic name
Warmer, Blood, Nonelectromagnetic Radiation
Manufacturer
3m CompanyModel number
24355Catalog number
24355
Lot number
HX9811
Product problems
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A user facility reported a 3M¿ Ranger¿ Blood/Fluid Warming High Flow Set leaked. No injuries or medical interventions were required due to the alleged malfunction.
Additional Manufacturer Narrative
The device was returned to Solventum for analysis. Based on the photo and video provided by the customer and testing of the returned device, a heat exchanger leak was confirmed. However, the root cause of the leak could not be determined. Possible causes of heat exchanger leaks include over-pressurization above 300mmHg, insertion or removal of pressurized heat exchanger from heating unit, and heat exchanger not fully inserted into the heating unit. A review of the batch record showed this lot met all specification for product release and no deviations were found that could have caused or contributed to the reported malfunction. Solventum will continue to monitor.