MAUDE Adverse Event Report: ORIGEN BIOMEDICAL, INC CRYOSTORE CS500N; CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Model Number CS500N

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2021

Event Type  malfunction  

Event Description

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).

• Brand Name: CRYOSTORE CS500N
• Type of Device: CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS
• Manufacturer (Section D): ORIGEN BIOMEDICAL, INC
• MDR Report Key: 12561773
• MDR Text Key: 274538097
• Report Number: MW5104308
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS500N
• Device Lot Number: W21779
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR