MalfunctionMEB
INFUSOR
Received Jul 17, 2026 · Event occurred Jun 17, 2026
Report 1416980-2026-02372 · MDR key 25862054
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C1009KCatalog number
2C1009K
Lot number
25G001
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED FROM THE BLADDER. THE DEVICE WAS FILLED WITH FLUOROURACIL AND 120ML OF GLUCOSE. THIS WAS OBSERVED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER FACILITY NAME: (B)(6) COLLEGE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.