inforMED
MalfunctionMEB

FOLFUSOR

Received Jul 13, 2026 · Event occurred Jun 12, 2026

Report 1416980-2026-02306 · MDR key 25803596

Device

Generic name

Pump, Infusion, Elastomeric

Model number

2C4702K

Catalog number

2C4702K

Lot number

25K003

Product problems

  • Failure to Infuse

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR HAD NO FLOW DURING PATIENT INFUSION. THE ISSUE WAS DESCRIBED AS, AFTER APPROXIMATELY 48 HOURS, IT WAS NOTED THAT THE VOLUME HAD NOT CHANGED, NO INFUSION HAD OCCURRED. THE DEVICE WAS FILLED WITH 64 ML OF 5 FLUOROURACIL AND 96ML OF GLUCOSE 5%. 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.