MalfunctionGKT
SPECTRA OPTIA
Received Sep 23, 2024 · Event occurred Apr 16, 2024
Report 20278455 · MDR key 20278455
Device
Generic name
Separator, Automated, Blood Cell, Diagnostic
Manufacturer
Terumo Bct, Inc.Catalog number
12320
Lot number
2309283141
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
OPTIMA - APHERESIS MACHINE DURING SET UP WHEN PRIMING TUBING TERUMOBCT APHERESIS TUBING -SCREEN READ OUT "TUBING SET IDENTIFICATION ERROR OCCURED" ON SET THAT WAS LOADED. BARCODE STICKER WAS DEFECTIVE MISPLACED/SLANTED.