FOLFUSOR
Received Jun 26, 2026 · Event occurred May 28, 2026
Report 1416980-2026-02148 · MDR key 25638341
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
23N006
Product problems
- Failure to Infuse
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER POSTAL CODE: (B)(6). 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 DID NOT EMPTY DURING PATIENT INFUSION. AFTER 3 DAYS OF INFUSION, THE DEVICE STILL APPEARED FULL. THE DEVICE WAS FILLED WITH 2718 MG OF FLUOROURACIL IN 115 ML OF 0.9% SODIUM CHLORIDE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.