FOLFUSOR
Received Jul 7, 2026
Report 1416980-2026-02255 · MDR key 25741195
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
25J017
Product problems
- Excess Flow or Over-Infusion
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 OVER INFUSED DURING PATIENT INFUSION. THE DEVICE COMPLETED THE INFUSION IN 13 HOURS. THE DEVICE WAS FILLED WITH 115 ML OF AN UNSPECIFIED DRUG SOLUTION AND DELIVERED THE INFUSION AT AN APPROXIMATE RATE OF 8.8 ML/HR, INSTEAD OF THE EXPECTED 2.5 ML/HR. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.