MalfunctionLKN
SPECTRA OPTIA
Received May 18, 2016 · Event occurred Apr 28, 2016
Report 5662246 · MDR key 5662246
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Catalog number
10310
Lot number
01Z3220
Product problems
- Kinked
Patient
24 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
TUBING REMOVED FROM PACKAGING, A SECTION OF THE TUBING WAS VISUALIZED TO BE KINKED. TUBING NOT USED DUE TO THE KINKING.