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 Death (1802); Multiple Organ Failure (3261)

Event Date 02/15/2017

Event Type  Death  

Manufacturer Narrative

The model and serial number are unknown, and the unique identifier (udi) number could not be determined.This information will be provided in a supplemental report if made available.As the model number is unknown, the 510(k) number could not be determined.This information will be provided in a supplemental report if made available.As the serial number was not provided, 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.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication, livanova (b)(4) learned that seven heater-cooler devices were used between 2011 until 2012.It could not be determined which device was used during the relevant surgeries.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 the surgeries the device was placed inside the operating theatre as far as possible from the patient with the exhaust air directed away from the surgery-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 customer stated that cleaning protocols from 2011 are no longer available.More current cleaning protocols have not been provided by the facility.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

Livanova (b)(4) received a report that a patient died of multi-organ failure on the second post-operative day following surgery of an aneurysm spurium in the area of the aorta root.The report indicated that the patient had undergone an aortic valve replacement in (b)(6) 2011, a re-operation of cerebral and coronary embolisms in thrombogenic arthroplasty with aortic valve endocarditis in (b)(6) 2012, and re-operation of an aneurysm spurium in the area of the aorta root with suspected endocarditis in (b)(6) 2017.The procedures in 2011 and 2012 involved the use of a heater-cooler system 3t.Diagnostics performed on resected aortic valve septum and ring material identified atypical mycobacteria in the patient.

• 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: 6415620
• MDR Text Key: 70296730
• Report Number: 9611109-2017-00202
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052601
• 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: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• 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: 02/17/2017
• 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: 72 YR