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

Catalog Number	200-074-402
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a cracked cryomacs freezing bag 500.Six bags were frozen, for one leakage was observed during thawing.The leakage was caused by a tear at the bottom edge.This bag was not transplanted.This was without harm for the patient, as enough material was available.The bag was not investigated.A filled questionnaire and pictures were available.According to the questionnaire the following investigation and statements could be made: the event was observed during thaw.The customer did use a metal cassette for freezing and for storage, but not for transport.A controlled rate freezer was used.No overwrap bag was used for freezing.The filling volume was 85 ml (55-100 ml are recommended).The cryomacs freezing bag was stored in the liquid phase of ln2 and placed in vapor phase prior to removal from the storage tank.According to the pictures the cryomacs freezing bag is cracked at one of the edges of the bag near the lot number.The picture shows, that there is a big label put onto the bag.It looks like the crack is leading from the label towards the corner.Air bubbles can be seen between the label and the eva foil of the cryomacs freezing bag.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with a wrong user handling.There are several deviations from the recommended freezing procedure, e.G.No overwrap bag is used for freezing.Another deviation is the labeling.It is recommended to place an identification tag into the label pocket of the freezing bag.It cannot be excluded, that a label put onto the freezing bag affects the product safety during the freezing process.According to the pictures there are air bubbles between the label and the eva foil of the cryomacs freezing bag and it looks like the crack is leading from the label towards the corner.In this case the issue is likely caused due to the additional labeling.The cryomacs freezing bags were stored in the liquid phase of ln2 and placed in vapor phase prior to removal from the storage tank.The bags were taken out of the container, the metal cassette was removed and then the bags were put back into a transport container with ln2.This transport can be another possible cause.The bags are very sensitive when frozen.It is important that any unavoidable short distance transport is performed carefully.The protective metal cassette would help.For the freezing bag 500 batch 7200200316, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.A review of the complaint database showed that 3 similar incidents have been reported for this lot before.The incident rate for this failure is below 0.02%.

• 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: 13869805
• Report Number: 3005290010-2022-00002
• Device Sequence Number: 5562654
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 4049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/23/2022

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: 200-074-402
• Device Lot Number: 7200200316
• 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: 01/26/2022
• Initial Report FDA Received Date: 03/23/2022
• 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