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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 50
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MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 50 Back to Search Results
Model Number FREEZING BAG 50
Device Problem Crack (1135)
Patient Problem Thromboembolism (2654)
Event Date 02/12/2015
Event Type  malfunction  
Event Description
When the customer pulled one cryomacs freezing bag 50 out of the liquid nitrogen tank the overwrap bag had cracked.During thawing the customer noted a blood leakage on the right lower corner of the cryomacs freezing bag 50.Consequently, the customer lost the cellular product which was part of a master cell bank for plasmacytoid dendritic cells consisting of 385 bags in total.Based on the information provided so far it can be stated that there is no harm for the patients because there are still 384 bags left intact.The event happened at: (b)(6).See scanned pages.
 
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Brand Name
CRYOMACS FREEZING BAG 50
Type of Device
CRYOMACS FREEZING BAG 50
Manufacturer (Section D)
MILTENYI BIOTEC GMBH
friedrichebertstrasse 68
bergisch gladbach
GM 
Manufacturer (Section G)
MILTENYI BIOTEC GMBH
friedrichebertstrasse 68
Manufacturer Contact
nancy johansen
85 hamilton st.,
cambridge, MA 02139
6172180062
MDR Report Key4964923
MDR Text Key23536349
Report Number3005290010-2015-00001
Device Sequence Number1
Product Code KSR
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
BK090020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Report Date 06/01/2015
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
Device Operator Health Professional
Device Expiration Date12/31/2015
Device Model NumberFREEZING BAG 50
Device Catalogue Number200-074-400
Device Lot Number6121128005
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/25/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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