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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA PLC STOCKERT 3T HEATER-COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA PLC STOCKERT 3T HEATER-COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Fever (1858); Granuloma (1876); Unspecified Infection (1930); Weight Changes (2607)
Event Date 04/28/2016
Event Type  Injury  
Event Description

Sorin heater-cooler issue: suspicion of ntm infection related to aortic valve replacement in (b)(6) 2016. The patient has many concerning symptoms (fevers, fatigue, weight loss) and labs (pancytopenia, lft elevation), as well as a recent bone marrow biopsy showing granulomas, suggestive of an atypical infectious process.

 
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Brand NameSTOCKERT 3T HEATER-COOLER
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA PLC
14401 west 65th way
arvada CO 80004
MDR Report Key8050655
MDR Text Key126555703
Report Number8050655
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/30/2018,10/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2018
Event Location Hospital
Date Report TO Manufacturer11/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/08/2018 Patient Sequence Number: 1
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