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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problems Abscess (1690); Bacterial Infection (1735); Pain (1994); Numbness (2415)
Event Date 02/19/2020
Event Type  Injury  
Event Description

This event involves a patient with a history of mitral valve replacement in early 2017; hyperlipidemia, hypertension, peripheral artery disease, and coronary artery disease with known thoracolumbar osteomyelitis and epidural spinal abscesses on daptomycin. The patient was recently admitted to hospital with worsening pain in his bilateral lower extremities, numbness in his anterior and lateral thighs, and progressive difficulty with urination. The patient underwent magnetic resonance imaging, which was notable for a slight increase in t3-4 and l4-5 abscesses. Nearly a week later, the patient underwent multi-level laminectomy and fusion for abscess drainage. A wound culture was sent on that day and processed in a reference lab and came back positive for mycobacterium chimera. M. Chimera infections have been previously linked to the use of the sorin heater-cooler at other institutions and can occur years after the cardiac surgical procedure. A sorin heater-cooler was in use at the time of this patient's mitral valve replacement back in early 2017. The patient will require prolonged treatment for the m. Chimera infection. The patient was discharged to an acute inpatient rehabilitation setting.

 
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Brand NameHEATER-COOLER SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
14401 west 65th way
arvada CO 80004
MDR Report Key9915422
MDR Text Key186112395
Report Number9915422
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 03/25/2020,03/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/14/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2020
Event Location Hospital
Date Report TO Manufacturer04/02/2020
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: 04/02/2020 Patient Sequence Number: 1
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