FOLFUSOR
Received Jun 24, 2026 · Event occurred May 19, 2026
Report 1416980-2026-02128 · MDR key 25615035
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4063KCatalog number
2C4063K
Lot number
25K019
Product problems
- Insufficient Flow or Under Infusion
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME FOLFUSOR HAD A SIGNIFICANT AMOUNT OF FLUID LEFT AFTER AN ADDITIONAL 17HOURS OF THE EXPECTED TIME. THE ISSUE WAS NOTICED AFTER PATIENT USE. THE DEVICE WAS FILLED WITH 4888MG FLUOROURACIL IN 0.9% SODIUM CHLORIDE HAVING A TOTAL VOLUME OF 240ML. THE EXPECTED INFUSION TIME WAS 24HOURS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.