FOLFUSOR
Received Jun 26, 2026
Report 1416980-2026-02158 · MDR key 25641420
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4009KCatalog number
2C4009K
Lot number
25F006
Product problems
- Excess Flow or Over-Infusion
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT TWO (02) LARGE VOLUME FOLFUSORS OVER INFUSED DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH 5 FLUOROURACIL (5FU). THE INFUSION WAS COMPLETED EARLIER THAN EXPECTED; AT APPROXIMATELY 38 TO 39 HOURS INSTEAD OF 44 HOURS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.