INFUSOR
Received Jul 15, 2026 · Event occurred Apr 22, 2026
Report 1416980-2026-02327 · MDR key 25824095
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C1009KCatalog number
2C1009K
Lot number
25F001
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 THE FLOW RATE OF A LARGE VOLUME INFUSOR WAS FASTER THAN EXPECTED DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH FLUOROURACIL AND 120ML OF SALINE. THE EXPECTED INFUSION DURATION WAS 48 HOURS; HOWEVER, THE INFUSION WAS COMPLETED IN 42 HOURS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.