MalfunctionGKT
SPECTRA OPTIA®
Received Nov 16, 2023 · Event occurred Feb 14, 2023
Report 18147602 · MDR key 18147602
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Lot number
2211216241
Patient
23360 DA · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PATIENT WAS UNDERGOING APHERESIS STEM CELL COLLECTION. HEALTHCARE PROVIDERS IDENTIFIED RETURN PRESSURE ALARMS WITH POOR FLOW. UNABLE TO OBTAIN BLOOD FLOW GREATER THAN 50-60ML/MIN. FLUSHING, REVERSING AND REPOSITIONING OF PATIENT WAS ATTEMPTED WITHOUT CHANGE TO. UPON INSPECTION OF TUBING DURING ATTEMPTS AT FIXING RETURN FLOW, IDENTIFIED HERMETIC SEAL ON RETURN LINE. NEW KIT SET-UP/PRIMED. NO OTHER EXPERIENCED ONCE KIT CHANGED.