MalfunctionMEB
FOLFUSOR
Received Jun 18, 2026
Report 1416980-2026-02083 · MDR key 25549933
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4700KCatalog number
2C4700K
Lot number
24D028
Product problems
- Failure to Infuse
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6). 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 NO FLOW. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND 5% GLUCOSE WITH FINAL VOLUME OF 85ML. AFTER 3 DAYS, THE WEIGHT WAS APPROXIMATELY EQUAL TO THE INITIAL WEIGHT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.