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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 12-80-10
Device Problem Difficult to Open or Close (2921)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova manufactures the electrical venous occluder (evo) the incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that a electrical venous occluder (evo) displayed an error code associated to the clamp closed position issue at the startup.There was no patient involvement.
 
Manufacturer Narrative
H.10: the unit was requested for investigation which confirmed the reported error code.The investigation results revealed that the linear actuator of the clamp was faulty and did not allow the clamp to close.The part will be replaced in order to solve the reported issue.
 
Event Description
See initial report.
 
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Brand Name
ELECTRICAL VENOUS OCCLUDER (EVO)
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key10984027
MDR Text Key220686342
Report Number9611109-2020-00681
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K082344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number12-80-10
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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