MalfunctionFPA
CLEARLINK SYSTEM SOLUTION SET WITH DUO-VENT SPIKE
Received Jan 5, 2026 · Event occurred Dec 24, 2025
Report MW5181722 · MDR key 23959376
Device
Generic name
Set, Administration, Intravascular
Manufacturer
Baxter Healthcare Of Puerto Rico Llc.Lot number
(10)R25J11154
Patient
78 YR · Male
- Chemical Exposure
Narrative
Description of Event or Problem
THE TUBING LEAKED AFTER BEING HOOKED UP TO THE PATIENT, INADVERTENTLY EXPOSING STAFF, PATIENTS AND VISITORS TO HARMFUL INFUSIONS INCLUDING BUT NOT LIMITED TO CHEMOTHERAPEUTIC AGENTS (OXALIPLATIN). IT APPEARS THE LEAK IS ORIGINATING FROM THE CONNECTION BETWEEN THE WHITE HUB AND TUBING. DUE TO THE HOSPITALS USE OF BAXTER IV PUMPS IT WAS NOT POSSIBLE TO SUB TO ANOTHER TUBING DURING THIS TIME.