MalfunctionMEB
FOLFUSOR
Received Jul 9, 2026 · Event occurred Jun 8, 2026
Report 1416980-2026-02269 · MDR key 25762933
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4063KCatalog number
2C4063K
Lot number
25H003
Product problems
- Fluid/Blood Leak
Patient
Not reported
- 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 THERE A LARGE VOLUME FOLFUSOR WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS OBSERVED DURING STORAGE OF THE DEVICE PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.