FOLFUSOR
Received Jul 1, 2026 · Event occurred May 22, 2026
Report 1416980-2026-02204 · MDR key 25678644
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
D2C4711KCatalog number
D2C4711K
Lot number
25K009
Product problems
- No Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE NO. - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH A SMALL VOLUME FOLFUSOR. THE EXPECTED THERAPY TIME WAS 46 HOURS; HOWEVER, IT WAS OBSERVED THAT THE DEVICE DID NOT DELIVER ANY OF THE FLUOROURACIL DOSE. THE DEVICE WAS FILLED WITH FLUOROURACIL AND SALINE. THIS ISSUE WAS OBSERVED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.