INFUSOR
Received Jun 15, 2026 · Event occurred May 14, 2026
Report 1416980-2026-02008 · MDR key 25513744
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
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6). 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 COMPLETED THE INFUSION 5 HOURS EARLIER. THE ISSUE OCCURRED DURING PATIENT INFUSION VIA PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE DEVICE WAS FILLED WITH 240ML FLUOROURACIL AND SALINE. THE EXPECTED INFUSION TIME WAS 48 HOURS; HOWEVER, THE ACTUAL INFUSION TIME WAS 43HOURS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.