FOLFUSOR
Received Jul 16, 2026 · Event occurred Jun 12, 2026
Report 1416980-2026-02340 · MDR key 25839878
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
25F005
Product problems
- Filling Problem
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 INFUSION. IT WAS OBSERVED THAT THE DEVICE DID NOT FINISH INFUSING THE EXPECTED MEDICATION DOSE (ONLY INFUSED 1/3 OF THE WAY THROUGH THE BLADDER VOLUME). THE DEVICE WAS FILLED WITH FLUOROURACIL HS (ACCORD) 3912MG IN SODIUM CHLORIDE 0.9%. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.