INFUSOR
Received Jun 15, 2026 · Event occurred Apr 12, 2026
Report 1416980-2026-02006 · MDR key 25513710
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C1009KCatalog number
2C1009K
Lot number
25F001
Product problems
- Fluid/Blood Leak
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 LEAKED AND LIQUID FLOWED OUT OF THE TUBING. THE ISSUE OCCURRED AFTER THE LIQUID WAS DRAWN AND INJECTED INTO THE DEVICE. THE DEVICE WAS FILLED WITH 4G OF FLUOROURACIL AND 70ML OF NORMAL SALINE. THE EXPECTED INFUSION TIME WAS 46 HOURS. THE LIQUID WAS RE-DRAWN AND INJECTED INTO THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.