FOLFUSOR
Received Jul 3, 2026 · Event occurred Jun 5, 2026
Report 1416980-2026-02231 · MDR key 25702786
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
D2C4705KCatalog number
D2C4705K
Lot number
24N001
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR LEAKED, WITH FREE LIQUID OBSERVED 'BETWEEN THE PAINT CAP AND THE PLASTIC BODY WHERE THE BALLOON IS LOCATED'. THE LEAK WAS IDENTIFIED DURING REMOVAL OF THE DEVICE FROM THE TRANSPORT CONTAINER AND PREPARATION FOR ADMINISTRATION. THE DEVICE WAS FILLED WITH 104 ML 5-FLUOROURACIL AND 17 ML 0.9% SALINE, RESULTING IN A TOTAL FILL VOLUME OF 121 ML. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER FIRST NAME: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.