MAUDE Adverse Event Report: ORIGEN BIOMEDICAL CRYOSTORE FREEZING BAG

Model Number CRYOSTORE 250 EVA BAGS

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 04/18/2014

Event Type  malfunction  

Event Description

Autologous peripheral blood stem cells were frozen in two origen cryostor freezing bags.The cells were frozen with cryoprotectant in controlled rate freeze and placed in a vapor phase liquid nitrogen storage container until day of transplant.Upon removal of patient's autologous stem cell product bags from frozen storage a large crack across the face of one of the bags was observed.Due to the potential risk of contamination it was determined by patient's medical staff that the product should not be infused into the patient.

• Brand Name: CRYOSTORE FREEZING BAG
• Type of Device: CRYOSTORE FREEZING BAG
• Manufacturer (Section D): ORIGEN BIOMEDICAL; austin TX 78744
• MDR Report Key: 4046857
• MDR Text Key: 20755424
• Report Number: MW5037940
• Device Sequence Number: 1
• Product Code: KSR
• Reporter Country Code: US
• 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: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: CRYOSTORE 250 EVA BAGS
• Device Catalogue Number: CS250N
• Device Lot Number: M50077-1N
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 112