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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 200-074-400
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2016
Event Type  malfunction  
Event Description
The customer complained on a leaking dmso injection port of one cryomacs freezing bag 50.The product malfunction was detected prior to freezing during fluid transfer of cord blood.
 
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Brand Name
CRYOMACS FREEZING BAG 50
Type of Device
CRYOMACS FREEZING BAG 50
Manufacturer (Section D)
MILTENYI BIOTEC GMBH
friedrich-ebert-strasse 68
bergisch gladbach, 51429
GM  51429
Manufacturer (Section G)
MILTENYI BIOTEC GMBH
friedrich-ebert-strasse 68
bergisch gladbach, 51429
GM   51429
Manufacturer Contact
nancy johansen
85 hamilton st
cambridge, MA 02139
6172180062
MDR Report Key5967368
MDR Text Key55317639
Report Number3005290010-2016-00087
Device Sequence Number1
Product Code LPZ
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 09/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/13/2018
Device Model Number200-074-400
Device Catalogue Number200-074-400
Device Lot Number6150513007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2015
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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