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

Catalog Number	200-074-403
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf a: 3191 - opening causing substantial loss of material after thawing.
Event or Problem Description
The customer reported breakage of connector.A filled in questionaire about the freezing process was provided.No photo was provided and also no clear description of the incident.As the customer reported the case to his authority it is assumed that the cellular material was lost for the treatment.According to the questionnaire the following investigation and statements could be made: the event was observed during freezing/storage.The customer did not use a metal cassette for freezing or for storage.A controlled rate freezer was not used.An overwrap bag was not used.The filling volume is not known.The freezing bags were stored in the vapor phase of ln2.No pictures were provided.According to the description it is suspected that the cryomacs freezing bag is cracked at the connection of the bag to the eva tube.Due to lack of information no clear statement can be given.For the cryomacs freezing bag 750 batch 7230600613, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.When correctly used according to the instructions for use the accepted risk limit from the risk assessment is (b)(4).This is the second complaint of this type for this lot with a incident rate below (b)(4).Due to the fact that no picture was provided, a detailed root cause cannot be determined.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.According to the questionnaire there are several deviations from the recommended freezing procedure, e.G.Using a metal cassette for freezing and for storage and using an overwrap bag.No statement is made about the filling volume.The cryomacs freezing bags are very sensitive when frozen and it is strongly recommended to freeze the cryomacs freezing bags according to the recommended freezing procedure.

• 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
• Manufacturer Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 19070479
• Report Number: 3005290010-2024-00005
• Device Sequence Number: 12476059
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 04049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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 Catalogue Number: 200-074-403
• Device Lot Number: 7230600613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown