MalfunctionMEB
FOLFUSOR
Received Jul 1, 2026
Report 1416980-2026-02206 · MDR key 25679603
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
D2C4711KCatalog number
D2C4711K
Lot number
25K009
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 FOUR (04) SMALL VOLUME FOLFUSORS LEAKED FROM THE SEALED INJECTION PORT. THE ISSUE WAS DESCRIBED AS, FLUID WAS ACCUMULATING IN THE INJECTION PORT INSTEAD OF BEING FULLY TRANSFERRED INTO THE PUMP DURING THE FILLING PROCEDURE. THE DEVICE CONTAINED WITH FLUOROURACIL AND SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.