FOLFUSOR
Received Jun 19, 2026 · Event occurred May 18, 2026
Report 1416980-2026-02105 · MDR key 25566347
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
25M014
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR DID NOT EMPTY AS EXPECTED, AND A LARGE VOLUME REMAINED EVEN AFTER 48 HOURS. THE ISSUE WAS NOTICED AFTER PATIENT USE. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL (5 G/100ML) AND 63ML 5% DEXTROSE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.