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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COBE CARDIOVASCULARAPPARATUS, AUTOTRANFUSIONBRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM

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COBE CARDIOVASCULAR 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  
Manufacturer Narrative

The brat 2 autologous blood salvage system. The medwatch report indicated that the blood processed from the cell saver started to separate in the iv blood pump. Transfusion was discontinued before reaching the pt. The risk mgmt mgr was contacted and indicated that the processed blood appeared to be fine until it was pumped through the iv blood pump. At that point, the blood appeared to be hemolyzed with clumps. The risk management mgr stated that there was no pt involvement. The blood was not transfused to the pt. Sorin group usa requested to have the brat disposables returned for eval. The risk management mgr did not know if the disposable had been discarded. To date, the mgr has not responded regarding the disposition of the disposables. If the product is returned for eval, a follow-up report will be filed.

 
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Brand NameAPPARATUS, AUTOTRANFUSION
Type of DeviceBRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
Manufacturer (Section F)
COBE CARDIOVASCULAR
arvada CO 80004
Manufacturer (Section D)
SORIN GROUP ITALIA
via statale 12 nord, 86
mirandola modena
ITALY 41037
Manufacturer Contact
jack ellison, dir
14401 w. 65th way
arvada , CO 80004
(303) 467 -6306
Device Event Key1379855
MDR Report Key1314008
Event Key1252029
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
1 Patient Was Involved in the Event
Date FDA Received12/24/2008
Device Catalogue Number007250100
Device LOT Number0806240041
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? 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
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/24/2008 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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