inforMED
MalfunctionFPK

MEDEX

Received Jun 5, 2025 · Event occurred May 1, 2025

Report 22149060 · MDR key 22149060

Device

Generic name

Tubing, Fluid Delivery

Manufacturer

Icu Medical, Inc.

Model number

MX43860

Catalog number

MX43860

Lot number

6068363

Product problems

  • Detachment of Device or Device Component

Patient

30 YR · Unknown

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

Narrative

Description of Event or Problem

J-LOOP DISCONNECTING AT AN AREA ON THE DEVICE THAT DOESN'T SEEM AS THOUGH IT SHOULD DISCONNECT AT ALL. POSING A SIGNIFICANT BLEEDING RISK AS IT IS ATTACHED TO AN ARTERIAL LINE.