CRYOSTORE CS500N
Received Sep 30, 2021 · Event occurred Sep 27, 2021
Report MW5104308 · MDR key 12561773
Device
Generic name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Manufacturer
Origen Biomedical, IncModel number
CS500NLot number
W21779
Product problems
- Leak/Splash
- Material Puncture/Hole
Patient
65 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ORIGEN CRYOSTORE CS500N BAG WAS USED TO CRYOPRESERVE HPC, APHERESIS AUTOLOGOUS PRODUCT FOR A PATIENT. 100ML WAS CRYOPRESERVED IN THE BAG AND KEPT IN LIQUID NITROGEN VAPOR PHASE STORAGE. NO PROBLEMS WERE FOUND DURING CRYOPRESERVATION. THE BAG WAS THAWED AT THE PATIENT'S BEDSIDE. ONCE COMPLETELY THAWED, THE BAG WAS TURNED UPSIDE DOWN FOR INFUSION AND A LEAK WAS NOTICED FROM THE BAG. NO LEAK WAS SEEN DURING THAWING. A HOLE/BREAK BENEATH THE PORT WAS FOUND AS THE SOURCE FOR THE LEAK. THE PRODUCT WAS INFUSED WITH A SYRINGE TO PREVENT FURTHER LOSS. FDA SAFETY REPORT ID # (B)(4).