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

Model Number	74402
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports a cryomacs freezing bag 500 (product code 200-074-402) which shattered while being thawed at a patient's bedside.The bag contained cryopreserved stem cells for transplant.The bag began to expand immediately upon removal from liquid nitrogen vapour and shattered.For the freezing bag 500 batch 7211000574, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.This is the second incident of this type for this lot with a complaint rate below 0.01%.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.· a controlled rate freezer was not used.· an overwrap bag was used and welded, but not evacuated.· the filling volume was 98 ml (55 - 100 ml are recommended).· the freezing bag was stored in the vapor phase of ln2.According to the picture the freezing bag was cracked in the middle along the whole bag.It can be seen, that the overwrap bag was welded, but not evacuated.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with a wrong user handling.An overwrap bag was used for freezing and was welded, which can be seen on the pictures, but not evacuated.This is a deviation from the recommended freezing procedure.Air bubbles could have been trapped between the overwrap bag and the cryomacs freezing bag.Air should absolutely be avoided in the sealed freezing bags as it will expand after during thaw and may cause a bag breakage.It is really important to follow the recommendations for the freezing procedure as the bag material is sensitive.As stated in the datasheet the customer is asked to handle frozen bags with care.

• 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 Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 15931183
• Report Number: 3005290010-2022-00009
• Device Sequence Number: 17778235
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 04049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 12/07/2022

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 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: 11/10/2022
• Initial Report FDA Received Date: 12/07/2022
• 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