InjuryKSR

CS550S CRYOSTORE FREEZINGBAG

Received Oct 8, 2024 · Event occurred Aug 28, 2024

Report 1000160256-2024-00007 · MDR key 20402001

Device

Generic name

Cs50s

Manufacturer

Origen Biomedical, Inc.

Model number

CSS

Catalog number

CS50S

Lot number

W23832

Product problems

Device Contamination with Chemical or Other Material
Device Contamination with Chemical or Other Material

Patient

NA · Unknown

Insufficient Information
Insufficient Information

Narrative

Additional Manufacturer Narrative

INVESTIGATION IS ONGOING. ORIGEN HAS REACHED OUT TO OUR SUPPLIER FOR ADDITIONAL INFORMATION ABOUT ALUMINUM COMPONENTS IN THEIR FACILITY.

Description of Event or Problem

A FREE-FLOATING ALUMINUM PARTCLE WAS FOUND IN THE FINAL PRODUCT FOR KYMRIAH (LENGTH OF THE PARTICLE WAS 422 MICROMETERS). THIS RESULTED IN THE TREATMENT NOT BEING PROVIDED TO THE PATIENT.