MalfunctionFPB

MEDEX

Received Sep 6, 2022 · Event occurred Jun 6, 2022

Report 15360901 · MDR key 15360901

Device

Generic name

Filter, Infusion Line

Manufacturer

Smiths Medical Asd, Inc.

Model number

MX448HFB

Catalog number

MX448HFB

Lot number

4229720

Product problems

Fluid/Blood Leak

Patient

Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

LIPID FILTER LEAK ON BED. LIPID WAS RUNNING AT 1.83ML/HR. APPROXIMATELY LEAKED 10ML. LOT # 4229720. MANUFACTURER RESPONSE FOR SET EXT 1.2 NON-DEHP MICRON FILTER - LIPID FILTER, SET EXT 1.2 NON-DEHP MICRON FILTER - LIPID FILTER (PER SITE REPORTER) DISTRIBUTER WAS NOTIFIED AND INFORMED MANUFACTURER.