MalfunctionMEB
FOLFUSOR
Received Jun 16, 2026 · Event occurred May 18, 2026
Report 1416980-2026-02017 · MDR key 25520977
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
M2C4063KCatalog number
M2C4063K
Lot number
25D026
Product problems
- No Flow
Patient
47 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME FOLFUSOR DID NOT INFUSE AND THE DEVICE REMAINED FULL. THE ISSUE WAS NOTICED DURING PATIENT USE. THE DEVICE CONTAINED 8G FLUCLOXACILLIN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.