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); Headache (1880)

Event Date 11/27/2013

Event Type  Injury  

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication with the customer, livanova (b)(4) learned that the case has been reported to the cdc and the state dept.Of health.The cdc is reportedly trying to determine the strain of bacteria.The customer reported that the patient experienced very mild symptoms including minor headaches and some fever and was prompted to notify the hospital upon receipt of a notification from the hospital.The original surgery was coronary bypass and mitrovalve angioplasty.Through additional follow-up communication with the customer, livanova (b)(4) learned that the facility was unable to disclose further details identifying the patient.The customer reported that the device was placed inside the operating room during use.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device availability unknown.

Event Description

Livanova (b)(4) received a report that a patient tested positive for a mycobacterium chimaera infection in (b)(6) 2017 after undergoing a surgical procedure in (b)(6) 2013.It was reported that a heater-cooler system was used during the surgery.

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication with the customer, livanova (b)(4) learned that there are three devices that were potentially used during the patient's procedure, though serial numbers have not been provided.The customer does not know which device was used during the surgery.All three devices were tested and the results came back negative for mycobacterium chimaera.The customer reported that the patient is fine and that there were no long-term effects.At this time, no link has been made between the infection and the use of the heater-cooler device, and there is no reason to believe that the device was involved in any way.The facility is still trying to determine the genus of the bacteria identified in the patient, and to figure out where the bacteria originated.No further information has been provided.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• 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: 6662387
• MDR Text Key: 78227470
• Report Number: 9611109-2017-00474
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2017
• 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): Other