FOLFUSOR
Received Jul 7, 2026 · Event occurred Jun 8, 2026
Report 1416980-2026-02244 · MDR key 25733586
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
D2C4705KCatalog number
D2C4705K
Lot number
25M007
Product problems
- Crack
- 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 THE INJECTION NOZZLE OF A SMALL VOLUME FOLFUSOR WAS FOUND DEFECTIVE DUE TO A CRACK, RESULTING IN LEAKAGE OF THE ACTIVE INGREDIENT. THE LEAKAGE OCCURRED AT THE FILLING PORT AND WAS OBSERVED DURING FILLING, DESPITE THE FILLING PORT CAP REMAINING SEALED. THE DEVICE WAS FILLED WITH 9.315 ML 5-FLUOROURACIL (5-FU) AND 76.4 ML SALINE SOLUTION HAVING A FINAL VOLUME OF 85.715 ML. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.