OtherLGZ
Level 1 Mass Transfuser
Received Jul 18, 2026 · Event occurred Jul 18, 2026
Report MW6000037 · MDR key 50055069
Device
Generic name
Warmer, Thermal, Infusion Fluid
Lot number
6108618
Product problems
- Leak/Splash
- Defective Device
- Material Integrity Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Upon setting up machine and priming x2 set of lines, each set of tubing was leaking atthe Y point just below the two primed bags. PT: 4582. DEVICE: 1354, 2588, 2978. Reference Report: CDRH-50054805. This report references tubing set #2.