MalfunctionMEB

AVANOS

Received Jun 11, 2026 · Event occurred Jun 2, 2026

Report 25470260 · MDR key 25470260

Device

Generic name

Pump, Infusion, Elastomeric

Manufacturer

Avanos Medical, Inc.

Model number

CB6004-PF

Catalog number

CB6004-PF

Lot number

30345841

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WE WERE PREPARING A ONQ LAID ROPIVACAINE INFUSION DEVICE FOR A PATIENT AFTER SURGERY AND AFTER STARTING TO FILL IT, WE NOTICED IT WAS LEAKING AT A CONNECTION IN THE TUBING AFTER THE FILTER. IT WAS NOTICED QUICKLY SO ANOTHER PUMP WAS OBTAINED AND PREPARED FOR THE PATIENT.