MalfunctionMEB
INFUSOR
Received Jun 30, 2026 · Event occurred May 28, 2026
Report 1416980-2026-02194 · MDR key 25665561
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
Additional Manufacturer Narrative
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 WAS LEAKING FROM THE BLADDER. THE LEAK WAS OBSERVED PRIOR TO PATIENT USE. THE DEVICE WAS FILLED WITH 60ML OF NORMAL SALINE AND 180ML OF FLUOROURACIL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.