FOLFUSOR
Received Jul 17, 2026 · Event occurred Apr 15, 2026
Report 1416980-2026-02361 · MDR key 25856336
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
25H032
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · 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 UNDER-INFUSED DURING PATIENT INFUSION. AFTER TWO (2) DAYS OF EXPECTED THERAPY, APPROXIMATELY 50% WAS STILL PRESENT IN THE PUMP. THE DEVICE WAS FILLED WITH FLUOROURACIL AND SODIUM CHLORIDE 0.9%. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.