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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ELECTRICAL VENOUS OCCLUDER (EVO) CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND GMBH ELECTRICAL VENOUS OCCLUDER (EVO) CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 28-95-70
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
Event Type  Malfunction  
Manufacturer Narrative

There was no known patient involvement. Livanova (b)(4) manufactures the evo clamp. The incident occurred in (b)(6). Livanova initiated an investigation. Livanova service engineer visit the customer and performed: evo potentiometer check. Clear nvmem evo and occluder. Terminal recalibrated to end point. Function check and test run ok. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. ".

 
Event Description

Livanova received report related to clamp error 1538. No patient involvement reported.

 
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Brand NameELECTRICAL VENOUS OCCLUDER (EVO)
Type of DeviceCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key12376369
MDR Text Key268445192
Report Number9611109-2021-00474
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN Number12E01364
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number28-95-70
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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