MalfunctionMEB
INFUSOR
Received Jul 31, 2026 · Event occurred Jun 30, 2026
Report 1416980-2026-02531 · MDR key 50106764
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C1009KCatalog number
2C1009K
Lot number
25G001
Product problems
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that a Large Volume Infusor leaked from the fill port. The device was filled with 70ml of normal saline and 170ml of fluorouracil. This occurred during filling. There was no patient involvement. No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.