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

Model Number 74401

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2020

Event Type  malfunction  

Event Description

The client informed that during the thaw process, bag 2 was leaking fluid from the upper corner.The bag with the leak was not infused and this patient's product required a significant dose reduction so the patient was able to receive 2 out of 3 bags (around 92% of target total dose).For the investigation photos and a filled in questionnaire were available.The following investigation and statements could be made: the event was observed during thawing.The customer did use a metal cassette for freezing and for storage.A controlled rate freezer was used.During the cryopreservation in the controlled rate freezer an unplanned deviation occurred, where the temperature failed to drop as expected, resulting in an abnormal freezing profile and the cryopreservation was aborted.The product was transferred into a new controlled rate freezer and the cryopreservation was reinitiated.The freezing bag was not stored with an overwrap bag as it is recommended for cell rescue.The filling volume was 70 ml (30 ml - 70 ml are recommended).The investigation of the pictures clearly shows that a small piece of the bag is broken off.The investigation of the pictures shows, that the issue is likely caused by physical stress due to a mechanical impact.It is recommended to handle the freezing bag with particular care, especially when it is frozen.The use of the overwrap bag is mandatory to raise safety.The incident rate for this lot is low with (b)(4).

• Brand Name: CRYOMACS FREEZING BAGS 250
• Type of Device: CRYOMACS FREEZING BAGS 250
• 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: 10038732
• MDR Text Key: 191917732
• Report Number: 3005290010-2020-00013
• Device Sequence Number: 1
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK090020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: 74401
• Device Catalogue Number: 200-074-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1