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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complains a cryomacs freezing bag 500 (6190412008) that broke upon thawing.Pictures were available.A long crack occured across the surface of the bag.The patient received cells recovered from a sterile overwrap bag.The sample was not frozen with the overwrap bag but placed inside the bag for thawing.The patient received antibiotics along with the transplant.The cryomacs freezing bag probably broke due to physical stress during handling.The overwrap bag provided with the freezing bag was not used for storage to stabilize the bag, the bag was slightly overfilled and the provided information makes it likely, that either not all air was removed from the bag or the fluid was not evenly distributed inside the bag prior to freezing.All this is described in the product information sheet.A review of the complaints reported for this lot resulted in three similar cases (breakage upon thawing).The incident rate is very low with (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
• MDR Report Key: 9636102
• Report Number: 3005290010-2020-00004
• Device Sequence Number: 2922958
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: N/A
• Device Catalogue Number: 200-074-402
• Device Lot Number: 6190412008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1