INFUSOR
Received Jul 17, 2026 · Event occurred Jun 17, 2026
Report 1416980-2026-02358 · MDR key 25855295
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2009KCatalog number
2C2009K
Lot number
25M016
Product problems
- Insufficient Flow or Under 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 INFUSOR UNDER-INFUSED. THIS WAS OBSERVED DURING PATIENT INFUSION. THE EXPECTED THERAPY TIME WAS 48 HOURS; HOWEVER, 40 HOURS LATER, LESS THAN 20CC OF APPROXIMATELY 200ML SOLUTION HAD BEEN DISPENSED. THE DEVICE WAS FILLED WITH FLUOROURACIL AND SALINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.