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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500
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MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500 Back to Search Results
Catalog Number 200-074-402
Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
Customer was using a cryomacs freezing bag 500 and preparing sample freeze down.During this process, the customer noticed a leak.A part of the product was rescued, some cells were lost.The customer provided a video.
 
Event Description
Customer was using a cryomacs freezing bag 500 and preparing sample freeze down.During this process, the customer noticed a leak.A part of the product was rescued, some cells were lost.The customer provided a video.
 
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Brand Name
CRYOMACS FREEZING BAG 500
Type of Device
CRYOMACS FREEZING BAG 500
Manufacturer (Section D)
MILTENYI BIOTEC B.V. & CO. KG
friedrich-ebert-str. 68
bergisch gladbach, 51429
GM  51429
MDR Report Key12065371
MDR Text Key264051944
Report Number3005290010-2021-00012
Device Sequence Number1
Product Code KSR
UDI-Device Identifier04049934000294
UDI-Public4049934000294
Combination Product (y/n)N
PMA/PMN Number
BK090020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number200-074-402
Device Lot Number7200200316
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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