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 Problem Death (1802)

Event Date 01/01/2014

Event Type  Death  

Manufacturer Narrative

(b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).The facility owns and operates several heater-cooler systems at the facility, several of which are heater-cooler 1t devices, which are not distributed in the usa.Through a follow-up communication with the customer, (b)(4) learned that the customer does not know which device was used during the patient's procedure(s).The customer reported that all heater-cooler systems are currently in storage and are not in use, with the last unit removed from service in mid-2016.During procedures, the devices are placed inside the operating theatre as far as possible from the patient with the exhaust air directed away from the surgical field.The facility stated that microbiological testing has been performed from 2015 onward, and atypical mycobacterium has been identified in all heater-cooler devices.The samples were reportedly taken from the drain before performing a cleaning cycle.The current cleaning protocols have not been provided by the facility.It is unclear at this time if the reported infection is directly linked to the patient death.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

(b)(4) received a report that a patient was diagnosed with a mycobacterium chimaera infecton after undergoing a combined aortic valve vitium surgery in (b)(6) 2014.A heater-cooler system was used during the procedure.The patient underwent a second procedure in (b)(6) 2017 for endocarditis of the native aortic valve.The patient died two days after the second surgical procedure, on (b)(6) 2017.

• 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: 6449150
• MDR Text Key: 71388377
• Report Number: 9611109-2017-00234
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• 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): Death
• Patient Age: 65 YR