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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA APPARATUS, AUTOTRANFUSION BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM

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SORIN GROUP ITALIA APPARATUS, AUTOTRANFUSION BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM Back to Search Results
Catalog Number 007250100
Device Problem Clumping in device or device ingredient
Event Type  Other  
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Brand NameAPPARATUS, AUTOTRANFUSION
Type of DeviceBRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
Manufacturer (Section D)
SORIN GROUP ITALIA
via statale 12 nord, 86
mirandola modena 4103 7
ITALY 41037
Manufacturer Contact
jack ellison, dir
14401 w. 65th way
arvada , CO 80004
3034676306
MDR Report Key1314008
Report Number1718850-2008-00035
Device Sequence Number1
Product CodeCAC
Report Source Manufacturer
Source Type Health Professional,User facility
Remedial Action Other
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/24/2008
Device Catalogue Number007250100
Device LOT Number0806240041
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/02/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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