inforMED
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

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.