MalfunctionCAC
COBE 2991
Received Dec 14, 2017 · Event occurred Jul 12, 2017
Report 7117000 · MDR key 7117000
Device
Generic name
Apparatus, Autotransfusion
Manufacturer
Terumo Bct, Inc.Catalog number
90819
Lot number
04Z15002
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
DURING RED BLOOD CELL REDUCTION OF A BONE MARROW PRODUCT ON THE COBE 2991 , A SMALL LEAK OCCURRED AT THE TOP OF THE WASH SET. MANUFACTURER RESPONSE FOR CELL PROCESSING SET FOR COBE 2991, CELL PROCESSING SET (PER SITE REPORTER):