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

Model Number 16-02-80

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

The serial number is unknown, as the facility does not track which unit is used for a given procedure.The heater-cooler device 16-02-80 is not distributed in the usa.However, it is similar to the heater-cooler device 16-02-85, which is distributed in the usa (510(k) number: k052601).As the serial number is unknown, the device manufacture date cannot be determined.Livanova implemented a field safety notice for disinfection and cleaning of livanova heater-cooler devices.The z number is z-2076/2081-2015.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).The reporting facility (prince of wales private hospital) has reported that multiple heater-cooler devices have been found to be contaminated with mycobacterium chimaera (see medwatch reports 9611109-2017-00114, 9611109-2017-00115 and 9611109-2017-00116 for details on the units).The facility does not track which unit is used for a given procedure, so it is unknown which of these devices was used during the patient's procedure.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 tested positive for mycobacterium chimaera infection after undergoing an aortic valve replacement procedure that utilized a heater-cooler system 3t.

• 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: 6368678
• MDR Text Key: 68748419
• Report Number: 9611109-2017-00112
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 03/01/2017
• 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
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR