MAUDE Adverse Event Report: ORIGEN BIOMEDICAL, INC. CRYOSTORE

Model Number CS50

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

Customer reported that the drug product bag for batch 23kc4031 had leaked during infusion of the drug product.

• Brand Name: CRYOSTORE
• Type of Device: CRYOSTORE
• 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, TX 78744 ; 5124747278
• MDR Report Key: 18707270
• MDR Text Key: 336188240
• Report Number: 1000160256-2024-00002
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK030036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS50
• Device Lot Number: W22591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other