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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
Catalog Number 12-80-10
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2022
Event Type  malfunction  
Event Description
Livanova received report that a electrical venous occluder (evo) gave an error (ee1538) code associated to the clamp encoder during priming. There was no patient involvement.
 
Manufacturer Narrative
"there was no patient involvement. Livanova deutschland manufactures the electrical venous occluder (evo). The incident occurred in (b)(4). A livanova field service engeneer was dispatched the customer and the reported condition was confirmed: error message 1538 confirmed. The device has been functionally checked. The step screw, the env encoder board and ribbon cable were renewed. The clamp and hose have been calibrated, flash update performed and error memory cleared. The device was tested and returned successfully to customer. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. ".
 
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Brand NameELECTRICAL VENOUS OCCLUDER (EVO)
Type of DeviceCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key15109648
MDR Text Key296708401
Report Number9611109-2022-00365
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number12-80-10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2011
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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