MalfunctionMEB
FOLFUSOR
Received Jun 26, 2026 · Event occurred May 28, 2026
Report 1416980-2026-02173 · MDR key 25644072
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4063KCatalog number
2C4063K
Lot number
25H002
Product problems
- Filling Problem
Patient
Unknown
- 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 A LARGE VOLUME FOLFUSOR UNDER INFUSED DURING INFUSION. IT WAS OBSERVED THAT THE DEVICE UNDER INFUSED BY APPROXIMATELY 90%. THE DEVICE WAS FILLED WITH FLUCLOXACILLIN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.