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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP/LIVA NOVA REVOLUTION CENTRIFUGAL PUMP

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SORIN GROUP/LIVA NOVA REVOLUTION CENTRIFUGAL PUMP Back to Search Results
Lot Number 381419-2185
Device Problems Material Discolored (1170); Vibration (1674); Noise, Audible (3273)
Patient Problem No Information (3190)
Event Date 10/06/2016
Event Type  Injury  
Event Description
Approx 45 minutes after ecmo was initiated, i rattle/vibration noise was heard from the ecmo circuit. Upon further investigation, it was noted that the upper bearing of the disposable centrifugal pump head appeared darkened or burnt. The circuit required replacement.
 
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Brand NameREVOLUTION
Type of DeviceCENTRIFUGAL PUMP
Manufacturer (Section D)
SORIN GROUP/LIVA NOVA
arvada CO 80004
MDR Report Key6030367
MDR Text Key57680529
Report NumberMW5065394
Device Sequence Number1
Product Code DWA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number381419-2185
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/12/2016 Patient Sequence Number: 1
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