3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET
Received Jun 25, 2026 · Event occurred May 2, 2026
Report 2110898-2026-00048 · MDR key 25628209
Device
Generic name
Warmer, Blood, Nonelectromagnetic Radiation
Manufacturer
3m CompanyModel number
24355Catalog number
24355
Lot number
HX9969
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE SPIKE ON THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET DISCONNECTED FROM THE TUBING DURING TRANSFUSION, RESULTING IN LOSS OF THE BLOOD BAG. THERE WERE NO REPORTED INJURIES OR MEDICAL INTERVENTIONS ALLEGED AS A RESULT OF THE REPORTED MALFUNCTION.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO SOLVENTUM FOR ANALYSIS; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE PROBLEM DESCRIPTION, THE REPORTED ISSUE IS A SPIKE LEAK. A REVIEW OF THE BATCH RECORD SHOWED THIS LOT MET ALL SPECIFICATIONS FOR PRODUCT RELEASE AND NO DEVIATIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED MALFUNCTION. SOLVENTUM WILL CONTINUE TO MONITOR.