inforMED
MalfunctionGKT

SPECTRA OPTIA IDL SET

Received Feb 12, 2026 · Event occurred Jan 21, 2026

Report 24321234 · MDR key 24321234

Device

Generic name

Separator, Automated, Blood Cell, Diagnostic

Manufacturer

Terumo Bct, Inc.

Lot number

2509013441

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT CONNECTED TO OPTIA FOR STEM CELL COLLECTION. RN VISUALLY SPOTTED SLOW LEAK/DRIP COMING FROM THE SALINE FILTER ON THE OPTIA KIT. THE COLLECTION WAS PAUSED AND THE LMR [LABORATORY MANAGER/RESIDENT] WAS CALLED. PER LMR, COLLECTION IS TO BE DISCONTINUED, AND BLOOD IS NOT TO BE RE-INFUSED. PRODUCT WAS DISCONNECTED FROM OPTIA AND CRYOTHERAPY WAS CONTACTED. PATIENT WAS DISCONNECTED FROM OPTIA WITHOUT BLOOD BEING RE-INFUSED. VITAL SIGNS TAKEN AND CVC [CENTRAL VENOUS CATHETER] FLUSHED PER PROTOCOL.