MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAGS 250

Model Number	74401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On wednesday (b)(6) 2020, one of our bmt laboratory technologist was verifying the backup dose of cells (cryopreserved autologous hpc, aphersis) in storage for a patient who will undergo a second transplant as part of their cancer treatment.Their cells were collected on (b)(6) 2014 and (b)(6) 2014 and the backup cell dose has been in storage since this time.Upon visually inspecting the cryo bags while verifying the product cells are present and intact, the bmt technologist discovered a fracture on the left hand side of one of the cryo bags extending from the base of the bag to the top of the bag just under the access port.The patient has an acceptable cell dose to proceed to transplant with the remaining intact product.Review of deviation reporting does not indicate a trend of integrity failures in association with the affected cryo bag lot and/or any other lot of cryo bag.The complaint rate for this failure with this lot is very low with (b)(4).The customer provided pictures and a filled in questionaire for investigation.The investigation of the pictures shows, that the issue is likely caused by physical stress due to a mechanical impact.According to the questionnaire the missing overwrap bag is a deviation from the recommended freezing procedure.Regarding the described issue, this should not have an influence, but cannot be excluded.On one of the two pictures showed enclosed air bubbles near the spike connection and the connection of the eva tube.Air has to be absolutely avoided as it expands during thawing and can cause cracks.It can not be excluded that trapped air contributed or caused the crack.

• Brand Name: CRYOMACS FREEZING BAGS 250
• Common Device Name: CRYOMACS FREEZING BAGS 250
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 10245275
• Report Number: 3005290010-2020-00015
• Device Sequence Number: 18981165
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 74401
• Device Catalogue Number: 200-074-401
• Device Lot Number: 6121120003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1