inforMED
MalfunctionLKN

SPECTRA OPTIA®

Received Jun 10, 2022 · Event occurred May 7, 2022

Report 14653138 · MDR key 14653138

Device

Generic name

Separator, Automated, Blood Cell And Plasma, Therapeutic

Manufacturer

Terumo Bct, Inc.

Product problems

  • Fluid/Blood Leak
  • Noise, Audible

Patient

Unknown

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

Narrative

Description of Event or Problem

LOUD NOISE AND BLOOD NOTED IN CENTRIFUGE.