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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH/LIVANOVA USA, INC. STOCKERT HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY

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SORIN GROUP DEUTSCHLAND GMBH/LIVANOVA USA, INC. STOCKERT HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY Back to Search Results
Catalog Number 16-02-85
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fatigue (1849); Hepatitis (1897); Weakness (2145); Arthralgia (2355); Sweating (2444); Weight Changes (2607)
Event Date 10/30/2018
Event Type  Injury  
Event Description

On (b)(6) 2016: operative procedure - redo sternotomy and mitral valve repair. On (b)(6) 2018: liver biopsy revealed mild to moderate active (b)(6) with associated non-necrotizing granulomas (afb stains negative for afb and no fungal elements seen). On (b)(6) 2018: chest ct revealed granuloma in the right mid-lung. Bronchial specimen collected (b)(6) 2018, positive for mycobacterium avium complex. On (b)(6) 2018: patient presented with complaints of weakness, fatigue, chronic non-productive cough (approx 6 months) or greater, associated with new night sweats 2-3 times per week and 80 pound weight loss in about 1 year. Patient also described arthralgias which were not limited to one joint or area and were nonspecific. Functional status had declined. Blood cultures collected (b)(6) 2018. On (b)(6) 2018: patient presented with severe functional decline. Blood cultures final report dated (b)(6) 2018 with organism identified as mycobacterium chimaera. Differential diagnosis: suspected disseminated m. Chimaera associated with prior mvr in 2016.

 
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Brand NameSTOCKERT HEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND GMBH/LIVANOVA USA, INC.
arvada CO
MDR Report Key8325289
MDR Text Key135906758
Report NumberMW5083861
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number16-02-85
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/08/2019 Patient Sequence Number: 1
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