LEVEL 1 FLUID WARMER IV SET
Received Jun 24, 2026 · Event occurred Nov 4, 2025
Report 3012307300-2026-06372 · MDR key 25610867
Device
Generic name
Device, Warming. Blood And Plasma
Catalog number
DI-100---802
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH A PATIENT, IMMEDIATELY AFTER CONNECTING THE BLOOD TRANSFUSION SET TO THE BLOOD BAG, A LEAK OF BLOOD WAS OBSERVED AT THE Y-SITE WHERE THE TUBING CONNECTS TO THE DRIP CHAMBER. THE DEVICE WAS DISCONTINUED FROM USE. THE INCIDENT OCCURRED IN A HOSPITAL SETTING, INVOLVED A PATIENT, AND RESULTED IN NO HARM.