MalfunctionMEB
FOLFUSOR
Received Jul 16, 2026 · Event occurred Jun 1, 2026
Report 1416980-2026-02342 · MDR key 25840009
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4702KCatalog number
2C4702K
Lot number
25D009
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR WAS LEAKING FROM AN UNSPECIFIED LOCATION. IT WAS OBSERVED THAT THE DEVICE LEAKED FLUOROURACIL WITH THE CHEMOTHERAPY BAG. THIS ISSUE WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.