MalfunctionLKN
COBE 2991 CELL PROCESSING SET
Received Jun 6, 2018 · Event occurred May 9, 2018
Report 7572940 · MDR key 7572940
Device
Generic name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Manufacturer
Terumo Bct, Inc.Catalog number
90819
Lot number
08A15001
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING THE WASHING PROCEDURE OF A BONE MARROW PRODUCT ON THE COBE 2991, A SMALL TEAR FORMED AT THE EXIT PORT OF THE BAG.