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

Catalog Number	200-074-401
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	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a bag breakage after thawing.According to the questionnaire the following investigation and statements could be made: the events were observed on removal from tank and during thawing.The customer did use a metal cassette for freezing and thawing.A controlled rate freezer was used.An overwrap bag was not used for freezing.The filling volume was 64 ml (30 - 70 ml are recommended for cryomacs freezing bag 250).The freezing bag was stored in the gas phase of ln2.According to the pictures the cryomacs freezing bag 250 is cracked at the lower part of the bag.For the cryomacs freezing bag 250 batch 7220800467, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.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.There are deviations from the recommended freezing procedure.An overwrap bag was not used.The picture of the cryomacs freezing bag 250 shows an air bubble inside the frozen material.Air should absolutely be avoided in the welded cryomacs freezing bag as it will expand during the thawing process and may cause a bag breakage.A second possible reason in this case is that the bag and/or metall cassette was not carefully dried before freezing.A clear negative imprint of the defective part of the bag can be seen on the cassette indicating that an ice layer had formed between bag and cassette, resulting in the bag getting stuck to the cassette leading to a damage of the still frozen bag when opening the cassette.The complaint rate for this failure for this lot is below 0.01%.
Additional Manufacturer Narrative
Medical device problem code 3191 "opening causing substantial loss of material after thawing".

• 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
• Manufacturer Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 18118326
• Report Number: 3005290010-2023-00015
• Device Sequence Number: 7540512
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/13/2023

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 Catalogue Number: 200-074-401
• Device Lot Number: 7220800467
• 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: 10/17/2023
• Initial Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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