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.