FOLFUSOR
Received Jun 25, 2026 · Event occurred May 21, 2026
Report 1416980-2026-02137 · MDR key 25630581
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
25F005
Product problems
- Filling Problem
Patient
Female
- 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 UNDERINFUSED DURING PATIENT INFUSION. THE EXPECTED INFUSION TIME WAS 46 HOURS; HOWEVER, ACTUAL INFUSION TIME WAS 73 HOURS 9 MINUTES, WITH A SIGNIFICANT AMOUNT OF DRUG WAS REMAINING. THE DEVICE WAS FILLED WITH FLUOROURACIL 3576MG IN 115ML OF SODIUM CHLORIDE 0.9%. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.