MalfunctionMEB
FOLFUSOR
Received Jul 15, 2026
Report 1416980-2026-02336 · MDR key 25833213
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
25J025
Product problems
- Fluid/Blood Leak
Patient
NA · 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 TWO (2) SMALL VOLUME FOLFUSORS WERE LEAKING FROM THE FILL PORT. THE LEAKS WERE OBSERVED DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.