inforMED
MalfunctionMEB

FOLFUSOR

Received Jun 26, 2026 · Event occurred May 27, 2026

Report 1416980-2026-02174 · MDR key 25644176

Device

Generic name

Pump, Infusion, Elastomeric

Model number

2C4063K

Catalog number

2C4063K

Lot number

25H002

Product problems

  • Insufficient Flow or Under Infusion

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME FOLFUSOR UNDER INFUSED DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH 8000MG FLUCLOXACILLIN IN 230ML 0.9% SODIUM CHLORIDE. 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.