CRYOMACS FREEZING BAG 500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for CRYOMACS FREEZING BAG 500 manufactured by Miltenyi Biotec Gmbh.

Event Text Entries

[126973115] 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. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5081124
• MDR Report Key: 8046239
• Date Received: 2018-11-06
• Date of Report: 2018-11-02
• Date of Event: 2018-08-22
• Date Added to Maude: 2018-11-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CRYOMACS FREEZING BAG 500
• Generic Name: CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD COMPONENTS
• Product Code: KSR
• Date Received: 2018-11-06
• Model Number: CRYOMACS FREEZING BAG 500
• Lot Number: 6170615001
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MILTENYI BIOTEC GMBH
• Manufacturer Address: BERGISCH GLADBACH NORTH-RHINE-WESTPHALIA 51429 GM 51429

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-11-06