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Adverse Event Report

COBE CARDIOVASCULAR CML DUO DISPOSABLE BLOOD OXYGENATOR   back to search results
Catalog Number 050-222-000
Event Date 03/18/1997
Patient Outcome  Required Intervention;
Event Description

When detaching arterial temperature probe from oxygenator, the temperature probe well detached from the oxygenator and remained attached to the temperature probe. This resulted in blood loss and contamination of the cardiopulmonary bypass circuit. This occurred after termination of bypass. Pt did need blood transfusion. Pt ok.

 
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Brand NameCML DUO DISPOSABLE BLOOD OXYGENATOR
Type of DeviceBLOOD OXYGENATOR
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
COBE CARDIOVASCULAR
14401 w 65th way
arvada CO 80004 3599
Manufacturer (Section D)
COBE CARDIOVASCULAR
14401 w 65th way
arvada CO 80004 3599
Device Event Key104687
MDR Report Key106492
Event Key100105
Report Number106492
Device Sequence Number1
Product CodeDTZ
Report Source User Facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 04/02/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number050-222-000
Device LOT Number11B7506
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/18/1997
Event Location Hospital
Date Report TO Manufacturer04/02/1997
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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