MalfunctionMEB
FOLFUSOR
Received Jun 16, 2026
Report 1416980-2026-02033 · MDR key 25524468
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
25K021
Product problems
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER POSTAL CODE - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH A SMALL VOLUME FOLFUSOR. IT WAS OBSERVED THAT THERE WAS NO FLOW WHEN THE DEVICE CONNECTED TO THE PATIENT. THE DEVICE WAS FILLED WITH FLUOROURACIL AND DEXTROSE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.