inforMED
MalfunctionMEB

INFUSOR

Received Jul 17, 2026 · Event occurred Jun 11, 2026

Report 1416980-2026-02359 · MDR key 25855625

Device

Generic name

Pump, Infusion, Elastomeric

Model number

2C2063K

Catalog number

2C2063K

Lot number

25J030

Product problems

  • Insufficient Flow or Under Infusion

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR UNDER-INFUSED; ONLY 70% OF THE SOLUTION INFUSED DURING PATIENT USE. THE DEVICE WAS FILLED WITH CEFEPIME (AFT) 6000MG IN SODIUM CHLORIDE 0.9% 240ML. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER POSTAL CODE: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.