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

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a breakage during thawing.The bag was stored in liquid nitrogen for 2 months.The day before thawing it was removed from liquid nitrogen and stored in vapor phase for 18 hours.On the day of reinfusion, the bag was transferred to dry shiper.Before thawing the metal cassette was opened, the identification data were checked, and the bag appeared fine.But at the time when it was taken from shipper, and put to dry warming device sahara the overwrap bag expanded, and exploded.When the customer checked it, they found that the freezing bag was damaged too.The patient was treated with backup material.For this lot miltenyi biotec received reports about four bags affected by breakage related complaints (however with different failures and causes).The incident rate is (b)(4).The investigation showed that likely air or liquid nitrogen was trapped inside a bag.This is avoided if following the validated protocol.Therefore a handling error is assumed.

• 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: 9658735
• Report Number: 3005290010-2020-00007
• Device Sequence Number: 3172048
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 04049934000294
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 03/12/2022
• 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: 01/16/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1