LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS
Received Jun 24, 2026 · Event occurred Jun 1, 2026
Report 3012307300-2026-06373 · MDR key 25610912
Device
Generic name
Device, Warming, Blood And Plasma
Catalog number
DI-60HL
Lot number
6122902
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3. DATE OF EVENT IS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A BLOOD LEAK FROM THE IV ADMIN SET DURING USE. THERE WAS A PATIENT INVOLVEMENT AND THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES. HOWEVER, IF THE MALFUNCTION REOCCURS IT MAY LEAD TO EXPOSURE OF BLOOD OR MEDICATION TO THE PATIENT AND/OR HEALTHCARE PROFESSIONALS, POTENTIALLY POSING A RISK TO PATIENT SAFETY AND OVERALL, HEALTH.