MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 500; CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD COMPONENTS

Model Number CRYOMACS FREEZING BAG 500

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2018

Event Type  malfunction  

Event Description

Bmt lab technologist performed cell processing procedure for an autologous hpc, apheresis cellular therapy product (ctp) with unique id (b)(4) on (b)(6) 2018 in preparation for cryopreservation and long term ln2 vapor phase storage of the product.The technologist dispensed all components of the cryopreservation solution into the cryo bag without incident.During the final step of the processing procedure when dispensing the ctp aliquot into the cro bag containing the cryopreservation solution, the technologist observed a small amount of leakage of the cryo bag contents.Visual observation of the croy bag to locate the source of the leak revealed an integrity failure of a very small nick in the cryo bag material located at the base of the bag just above the bottom seam weld.The bmt lab technologist immediately initiated cell product rescue measures clamping off the affected area of the cryo bag to prevent add'l leakage of the product and worked quickly to transfer the product to a new intact cryo bag.The product was subsequently cryopreserved and stored in ln2 vapor phase storage without incident.The cell loss resulting from the leakage was determined to be minimal, however the product was sampled for sterility after transfer of the product to the secondary bag.Sterility testing was resulted as "no growth 14 days.".

• Brand Name: CRYOMACS FREEZING BAG 500
• Type of Device: CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD COMPONENTS
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; bergisch gladbach; north-rhine-westphalia 51429 ; GM 51429
• MDR Report Key: 8046239
• MDR Text Key: 126973115
• Report Number: MW5081124
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2020
• Device Model Number: CRYOMACS FREEZING BAG 500
• Device Lot Number: 6170615001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 60