InjuryKSR
ORIGEN EVOLVE 3000 ML CRYOPRESERVATION BAG
Received Oct 16, 2020 · Event occurred Sep 30, 2020
Report MW5097317 · MDR key 10699110
Device
Generic name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Manufacturer
Origen Biomedical, Inc.Model number
EV3000NCatalog number
EV3000N
Lot number
R29410-4N
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
EACH OF THE THREE PARTS BECOME UNATTACHED FROM THE STEM CELL TRANSFER BAG CONTAINING 1908 ML OF PERIPHERAL BLOOD DONOR STEM CELLS. THIS PRODUCT WAS COLLECTED FROM A VOLUNTEER DONOR FOR THE (B)(6) INTENDED FOR POTENTIAL LIFE- SAVING TRANSPLANTATION. FAILURE OF THIS PRODUCT RESULTED IN CONCERNS FOR PRODUCT CONTAMINATION, REDUCED PRODUCT VOLUME AND VIABILITY, ADDITIONAL LEAVING INCLUDING BACTERIAL CULTURES, CELL COUNTS AND DELAYS IN CARE OF THE INTENDED PATIENT.