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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 500
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MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 500 Back to Search Results
Model Number N/A
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2016
Event Type  malfunction  
Event Description
The customer complained on a leakage at the y-port of one cryomacs freezing bag 500 (cfb).The customer stated furthermore that they will test the cellular material for sterility and thereafter decide on the application for the patient.
 
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Brand Name
CRYOMACS FREEZING BAG 500
Type of Device
CRYOMACS FREEZING BAG 500
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 Key6047960
MDR Text Key58132058
Report Number3005290010-2016-00094
Device Sequence Number1
Product Code LPZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 10/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/10/2018
Device Model NumberN/A
Device Catalogue Number200-074-402
Device Lot Number6151210021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/23/2016
Date Device Manufactured03/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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