MalfunctionMEB
INFUSOR
Received Jun 19, 2026 · Event occurred May 22, 2026
Report 1416980-2026-02081 · MDR key 25562612
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2009KCatalog number
2C2009K
Lot number
25H028
Product problems
- Crack
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER FACILITY NAME: (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 FROM THE FILL PORT. A CRACK WAS OBSERVED AT THE FILLING PORT, WHICH CAUSED THE 5 FLUOROURACIL TO LEAK FROM THE DEVICE. THIS OCCURRED DURING FILLING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.