FOLFUSOR
Received Jun 15, 2026 · Event occurred May 17, 2026
Report 1416980-2026-02004 · MDR key 25513683
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
M2C4063KCatalog number
M2C4063K
Lot number
25D026
Product problems
- Excess Flow or Over-Infusion
Patient
NA · Unknown
- 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 LARGE VOLUME FOLFUSOR COMPLETED THE INFUSION BEFORE THE EXPECTED TIME. THE ISSUE OCCURRED DURING PATIENT INFUSION. THE EXPECTED INFUSION TIME WAS 24 HOURS; HOWEVER, THE ACTUAL INFUSION TIME WAS 20HOURS. THE DEVICE WAS FILLED WITH 8G FLUCLOXACILLIN WITH CITRATE BUFFER AND SODIUM CHLORIDE (NACL). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.