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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. SORIN 3T HEATER COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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LIVANOVA USA, INC. SORIN 3T HEATER COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Test Result (2695)
Event Date 02/12/2017
Event Type  malfunction  
Event Description
Bilateral lung transplant recipient who had surgery approximately 2 years ago.This patient was recently identified by department of id (infectious disease) to have positive test results for m.Chimera spore.This spore is possible related to the use of the liva nova (sorin) 3t heater coolers used by cardiac perfusion during cardiopulmonary bypass.At the time of consent for surgery the patient should also had a disclosure that these heater coolers will be in use as per fda and manufacturers recommendations.Department of id, perfusion and all regulatory and executive leadership are actively working with dph (department of public health) to identify and comply with all requests.
 
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Brand Name
SORIN 3T HEATER COOLER
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA USA, INC.
14401 west 65th way
arvada CO 80004
MDR Report Key9395057
MDR Text Key168644323
Report Number9395057
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/21/2019,11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2019
Event Location Hospital
Date Report to Manufacturer12/02/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age20440 DA
Patient Weight65
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