MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAGS 1000

Catalog Number	200-074-404
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The cryomacs bag was used for storing autologous blood product from a patient.The user found a leakage when wiping the bag after thawing.The affected blood sample was discarded and not used for the patient.The patient treatment was done with backup material.Cracks were found near the eva tube.According to the questionnaires filled in by the user, the following investigation and statements could be made: the event was observed during thawing.The customer did use a metal cassette for freezing but not for storage as it is recommended.A controlled rate freezer was not used.The freezing bag was stored with an overwrap bag for cell rescue.The overwrap bag was evacuated.The cells were stored in the liquid phase of ln2 and the bag was not stored in the vapor phase prior to the removal from the storage tank as it is recommended.The filling volume was 350 ml (125 ml - 270 ml are recommended).The location of the crack near the connection to the eva tube is marked on the picture.The investigation of the pictures shows, that the issue is likely caused by physical stress (e.G.Mechanical impact).According to the questionnaire, there are several deviations from the recommended freezing process, e.G.A storage without metal cassette, no use of controlled rate freezer or the bag not stored in vapor phase prior removal from the tank.The bag was overfilled (350 ml instead of 270 ml max.Filling volume).It is recommended to handle the frozen bags with care and use the bags according to the specification including not to overfill the bags, otherwise the functionality of the bags cannot be guaranteed.This is the first complaint concerning breakage of a freezing bag for this lot.

• Brand Name: CRYOMACS FREEZING BAGS 1000
• Common Device Name: CRYOMACS FREEZING BAGS 1000
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 10829263
• Report Number: 3005290010-2020-00020
• Device Sequence Number: 19836422
• Product Code: KSR
• UDI-Device Identifier: 04049934000317
• UDI-Public: 4049934000317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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 Catalogue Number: 200-074-404
• Device Lot Number: 6190205045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1