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

Catalog Number	200-074-402
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When unthawing 6 bags for an autologous transplantation, a defect was determined with one bag.According to the user there was no consequences for the patient, or others.This is the first reported complaint concerning breakage of bag with patient material lost for this lot.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 thawing.The customer did use a metal cassette for freezing but not for storage.A controlled rate freezer was used.The freezing bags were not stored with an overwrap bag for cell rescue.The filling volume was 100 ml (55 ml - 100 ml are recommended).The cells were stored in the liquid phase.According to the pictures of the freezing bag the bag is cracked at the edge at the bottom of the bag.The issue is likely caused by physical stress (e.G.Mechanical impact).According to the questionnaire the freezing bags were not stored with an overwrap bag and a metal cassette.This is a deviation from the recommended freezing procedure.Regarding to the described issue, this should not have an influence.After storage in the liquid phase the bags should be stored in the vapor phase before thawing.This deviation from the recommended freezing process may have had an influence.The pictures show a round piece of the bag materiel broken out.It looks as if an air bubble was trapped at this location.Air should absolutely be avoided in the freezing bag before freezing as it will expand after the freezing process and may cause a bag breakage.The customer is asked to handle frozen bags with care.For the freezing bag 500 batch#: 7200200316, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.

• 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: 10904180
• Report Number: 3005290010-2020-00019
• Device Sequence Number: 11096704
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 4049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/25/2020

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: 200-074-402
• Device Lot Number: 7200200316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1