MalfunctionMEB
FOLFUSOR
Received Jun 30, 2026
Report 1416980-2026-02199 · MDR key 25667783
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
M2C4711KCatalog number
M2C4711K
Lot number
25H033
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 A SMALL VOLUME FOLFUSOR HAD A 'LEAK/SPILL OF 5FU WHICH HAD DRIED AND CRYSTALIZED'. THE ISSUE WAS NOTICED WHEN REMOVED FROM THE PACKAGING PRIOR TO PATIENT USE. THE DEVICE WAS FILLED WITH 3150MG 5-FLUOROURACIL (5-FU) IN 0.9% SODIUM CHLORIDE HAVING A TOTAL VOLUME OF 115ML. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.