MAUDE Adverse Event Report: ORIGEN BIOMEDICAL, INC. CS550S CRYOSTORE FREEZINGBAG; CS50S

Model Number	CSS
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.Origen has reached out to our supplier for additional information about aluminum components in their facility.
Event or Problem Description
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.

• Brand Name: CS550S CRYOSTORE FREEZINGBAG
• Common Device Name: CS50S
• Manufacturer (Section D): ORIGEN BIOMEDICAL, INC.; 7000 burleson rd; building d; austin TX 78744
• Manufacturer (Section G): ORIGEN BIOMEDICAL, INC.; 7000 burleson rd; building d; austin TX 78744
• Manufacturer Contact: sam saleh ; 7000 burleson rd; building d; austin 78744 ; 5124747278
• MDR Report Key: 20402001
• Report Number: 1000160256-2024-00007
• Device Sequence Number: 3351768
• Product Code: KSR
• UDI-Device Identifier: 10816203021349
• UDI-Public: 10816203021349
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: BK030036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CSS
• Device Catalogue Number: CS50S
• Device Lot Number: W23832
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown