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

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.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, 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 Key: 6994845
• MDR Text Key: 90837667
• Report Number: 9611109-2017-00879
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• 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 Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 10/02/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other