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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN-LEE NOVA AFFINITY IF-6 OXYGENATOR

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SORIN-LEE NOVA AFFINITY IF-6 OXYGENATOR Back to Search Results
Model Number IF 6
Device Problem Device Inoperable (1663)
Patient Problem Low Oxygen Saturation (2477)
Event Date 02/10/2017
Event Type  malfunction  
Event Description
The pt was having cabg procedure when it was noted that the oxygen levels were low, the perfusionist checked the oxygen source, did abg's on 2 different machines then noted that the oxygenator was failing. The oxygenator was then changed out. The pt's vital signs and levels remained constant throughout the procedure. No residual effects or complications noted post procedure.
 
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Brand NameAFFINITY IF-6
Type of DeviceOXYGENATOR
Manufacturer (Section D)
SORIN-LEE NOVA
arvada CO 80004
MDR Report Key6331453
MDR Text Key67652686
Report NumberMW5067887
Device Sequence Number1
Product Code DTZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIF 6
Device Lot Number389331-0066
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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