MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500

Model Number	74402
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code: 3191: opening causing substantial loss of material after thawing.
Event or Problem Description
The customer reported a cracked bag after shipment between two facilities and decided to discard the product and treat the patient with backup material.A filled questionnaire and a picture was available.According to the questionnaire the following investigation and statements could be made: the event were observed during thaw.The customer did use metal cassettes for freezing and for storage.A controlled rate freezer was used.An overwrap bag was not used for freezing.The filling volume was 94 ml (55 - 100 ml are recommended).The freezing bag was stored in the vapor phase of ln2.Additionally it is described that the cassette with the bag inside slipped from a height of about 5 cm into the shipper before transport to another hospital.According to the pictures the bag is cracked over the entire bag.In the still frozen parts, trapped air bubbles and foam can be seen.There is an indication that a large air bubble might have been close to the center of the crack, however, it not possible to exclude that the bubble occured after the crack had formed.The issue is likely caused by physical stress, e.G.Mechanical impact during the transport in combination with an improper user handling during the freezing procedure.As the bag fell down in a frozen state it is not unlikely that this affected the integrity of the bag.A frozen bag is hard and brittle and very sensitive towards mechanical stress.Air bubbles and foam trapped inside the sealed bag must be avoided as they will expand during thawing and thereby can cause a bag breakage.According to the questionnaire no overwrap bag was used which is a deviation from the recommended freezing process.It is not recommended to transport the frozen freezing bags over long distances.This must be validated by the customer.For the cryomacs freezing bag 500 batch 7211000574, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The incident rate for this type of failure is (b)(4).

• Brand Name: CRYOMACS FREEZING BAG 500
• Common Device Name: CRYOMACS FREEZING BAG 500
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): 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: 16370171
• Report Number: 3005290010-2023-00003
• Device Sequence Number: 7843682
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 04049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/14/2023

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 Model Number: 74402
• Device Catalogue Number: 200-074-402
• Device Lot Number: 7211000574
• 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: 01/23/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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