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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fever (1858)
Event Date 04/12/2016
Event Type  Injury  
Manufacturer Narrative

The model and serial number are unknown. This information will be provided in a supplemental report if made available. Mfg date: as the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova (b)(4) manufactures the heater-cooler system 3t. It is not known where the incident occurred. This medwatch report is being filed on behalf of livanova (b)(4). At this time, it is unknown if the device utilized during surgery has tested positive for contamination, or if the use of the device is related in any way to the reported patient infection. As no device information or contact information for the facility or for the initial reporter was provided in the user medwatch report, livanova (b)(4) is unable to perform any follow-up with the customer regarding this event at this time. Due diligence was performed to ensure that there is no additional information regarding this event contained in an already existing complaint. A review of existing complaints did not identify any event that matched the description provided in the user report. No further investigation is possible. In the event of receipt of new information, a supplemental report will be provided. Device not returned.

 
Event Description

On (b)(6) 2017, livanova (b)(4) received a user medwatch report (mw5071934) stating that a patient developed a fever after undergoing an aortic root replacement in 2016 and a redo sternotomy ascending aortic root replacement with homograph tissue specimen collected in 2017. A heater-cooler system 3t was utilized during the 2016 procedure. The patient underwent another redo sternotomy and ascending aortic root replacement and cultures from the surgery tested positive for mycobacterium avium complex. Further specification of the bacteria is pending.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6994845
MDR Text Key90837667
Report Number9611109-2017-00879
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
PMA/PMN NumberK052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/01/2017 Patient Sequence Number: 1
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