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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 Clinical Signs, Symptoms or Conditions (4582)
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).The clamp was received at livanova japan and there was no reproduction of the reported issue.After technical analysis of the reported issue, it was concluded the dashes were not referring to the % of clamp opening as reported initially and that dashes appeared near the "%" symbol, indicating that the clamp may have been unplugged or defective.Functional tests performed revealed that the clamp worked properly and no problem could be found suggesting a connection issue between the occluder and its panel.An issue impacting closing/opening functions cannot be completely excluded.Therefore, as a conservative approach, this is considered a reportable event.The evo control panel was checked and there was no abnormality.The connector between the panel and the occluder was reconnected.The nvmem (memory) of the clamp was cleared and calibration and closing force adjusted by flashing new software revision.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 an electrical venous occluder (evo) displayed an error during circuit blood collection after the pump operation was completed.Reportedly, the error number was not displayed and only dashes appeared in the % of the opening display section.There was no report of patient injury.Furthermore, it was reported by the user that prior to this event, an error was previously displayed at the power up.The user turned off and back on the device twice with no improvement of the issue and 100% display appeared at the third time.Thus, the customer monitored the device for a while.
 
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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
lindberghstrasse 25
munich 80309
GM  80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM   80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key13903054
MDR Text Key287910910
Report Number9611109-2022-00127
Device Sequence Number1
Product Code DXC
UDI-Device Identifier04033817900504
UDI-Public(01)04033817900504(11)160905
Combination Product (y/n)N
Reporter Country CodeJA
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 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number12-80-10
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/23/2022
Initial Date FDA Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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