inforMED
MalfunctionMEB

INFUSOR

Received Jul 1, 2026 · Event occurred Apr 10, 2026

Report 1416980-2026-02212 · MDR key 25686208

Device

Generic name

Pump, Infusion, Elastomeric

Model number

2C2009K

Catalog number

2C2009K

Lot number

NI

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED MEDICATION, RESULTING IN A CHEMOTHERAPY SPILL. THE SOLUTION WAS NOTED ON THE PATIENT'S SKIN AND CLOTHING. THE ISSUE OCCURRED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.