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Adverse Event Report

DEKNATEL, INC. PLEUR-EVAC AUTOTRANSFUSION SYSTEM CHEST DRAINAGE & AUTOTRANSFUSION SYSTEM   back to search results
Event Date 10/11/1994
Patient Outcome  Death;
Event Description

Per lawsuit: autotransfusion system was used during open heart surgery. Shortly after surgery, decedent suffered a cardiac arrest, was unable to be resuscitated, and expired due to a massive air embolism. This report is based on info offered in a civil lawsuit.

 
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Brand NamePLEUR-EVAC AUTOTRANSFUSION SYSTEM
Type of DeviceCHEST DRAINAGE & AUTOTRANSFUSION SYSTEM
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DEKNATEL, INC.
600 airport rd
fall river MA 02722
Manufacturer (Section D)
DEKNATEL, INC.
600 airport rd
fall river MA 02722
Device Event Key29710
MDR Report Key28749
Event Key26916
Report Number28749
Device Sequence Number1
Product CodeCAC
Report Source Distributor
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 11/17/1995,11/16/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/1995
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/1995
Distributor Facility Aware Date11/13/1995
Device Agena
Event Location Hospital
Date Report TO Manufacturer11/14/1995
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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