FOLFUSOR
Received Jun 16, 2026 · Event occurred May 18, 2026
Report 1416980-2026-02011 · MDR key 25519938
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
24N014
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- 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 DURING PATIENT INFUSION. A SMALL AMOUNT OF SOLUTION FROM THE BALLOON WAS OBSERVED WITHIN THE BOTTLE. THE LEAK WAS CONTAINED WITHIN THE DEVICE HOUSING/CASING. THE DEVICE WAS FILLED WITH FLUOROURACIL 3528MG IN 115ML OF SODIUM CHLORIDE 0.9%. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.