MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 750

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a breakage of a cryomacs bag during thawing.The patient was treated with backup material.The customer sent pictures and a filled questionnaire for a more detailed investigation.The investigation of the pictures showed a crack in the bag.According to the questionnaire there were deviations from the recommended freezing procedure for handling the bag.The overwrap bag was not evacuated.It has to be noted, that all air has to be removed from the bag and the overwrap bag.Air in either bag has to be absolutely avoided as it expands during thawing and thereby can cause cracks.Equally critical is that the bag was stored in the liquid phase and not placed for at least 4 hours in the vapor phase prior to removal from the storage tank.Both steps are described in the instructions for use.The overwrap bag is used to rescue cells from a broken bag if necessary.It is likely that this did not happen as enough backup material was available.The incident rate for the lot used by the customer is low with (b)(4).

• Brand Name: CRYOMACS FREEZING BAG 750
• Common Device Name: CRYOMACS FREEZING BAG 750
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 9962147
• Report Number: 3005290010-2020-00011
• Device Sequence Number: 16829434
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 4049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: 01/20/2022
• Device Model Number: N/A
• Device Catalogue Number: 200-074-403
• Device Lot Number: 6190220015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1