MalfunctionMEB
FOLFUSOR
Received Jul 2, 2026 · Event occurred Jun 4, 2026
Report 1416980-2026-02228 · MDR key 25700290
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
24N014
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR LEAKED INSIDE THE BAG WHILE THE NURSE WAS ADMINISTERING THE DRUG. THE DEVICE WAS FILLED WITH 3250MG FLUOROURACIL IN 0.9% SODIUM CHLORIDE HAVING A TOTAL VOLUME OF 115ML. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.