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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND GMBH SORIN HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3T
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Bacterial Infection (1735)
Event Date 06/29/2020
Event Type  Injury  
Event Description
Patient was seen and evaluated at another facility this year. Patient had coronary artery bypass graft at our facility on (b)(6) 2018. When seen at the other facility this year, patient had blood cultures drawn and sent for mycobacterium chimaera. The culture was sent to investigate the possibility of this organism because it was associated with the use of heater-cooler units used during cardiac bypass surgery. Subsequent to receiving this information, we swabbed and sent culture of the heater/cooler unit for our bypass machine. The results of that culture came back positive for acid fast bacilli on (b)(6) 2020. These swabs are being sent for further differentiation and specification of organism. The samples are being for further differentiation and to rule out mycobacterium chimaera. Fda safety report id# (b)(4).
 
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Brand NameSORIN HEATER COOLER UNIT
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
arvada CO 80004
MDR Report Key10288693
MDR Text Key199455384
Report NumberMW5095558
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 Risk Manager
Type of Report Initial
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3T
Was Device Available for Evaluation? Yes
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: 07/16/2020 Patient Sequence Number: 1
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