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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 Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the electrical venous occluder (evo). The incident occurred in (b)(6). Review of the dhr could not identify any deviations or nonconformities relevant to the issue. The affected unit was sent to manufacturer for investigation and the reported issue was not reproduced. As per maintenance interventions prevention, the encoder board and ribbon cable were replaced. It cannot be ruled out that an intermittent faulty connection between the encoder board and the ribbon cable occurred leading to the reported event.
 
Event Description
Livanova (b)(4) received a report that a electrical venous occluder (evo) was giving an error message associated to the encoder during setup. There was no patient involvement.
 
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Brand NameELECTRICAL VENOUS OCCLUDER (EVO)
Type of DeviceCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10761531
MDR Text Key213891553
Report Number9611109-2020-00610
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K082344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 10/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number12-80-10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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