INFUSOR
Received Jul 10, 2026 · Event occurred Jun 10, 2026
Report 1416980-2026-02285 · MDR key 25778291
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2009KCatalog number
2C2009K
Lot number
25M016
Product problems
- Excess Flow or Over-Infusion
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME INFUSOR OVER INFUSED DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH FLUOROURACIL 4100MG IN 230ML OF 5% DEXTROSE. THE EXPECTED INFUSION DURATION WAS 46 HOURS; HOWEVER, THE INFUSION COMPLETED IN 30.5 HOURS, APPROXIMATELY 15.5 HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.