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

Model Number 16-02-82

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/18/2016

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.This information will be provided in a supplemental report if made available.Recall number: livanova (b)(4) implemented a field safety notice for disinfection and cleaning of 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).A review of the dhr for all devices which were delivered to the customer did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) learned from tv news and an article that a patient died from a mycobacterium chimaera infection.It was reported that a heater-cooler system 3t was used.

Manufacturer Narrative

Livanova (b)(4) received the information that the patient age was (b)(6) and the date of birth was the (b)(6).The date of event was provided.((b)(6) 2016).Through follow-up communication with the customer livanova (b)(4) received the information that total six heater cooler systems 3t, were used during that period.All the unit were replaced with seven devices that have undergone the retrofit upgrading procedure.Since it is unknown the serial number of the heater cooler system unit that was used during surgery no further investigation could be performed.With the information provided the relation between the involved device and patient contamination cannot be confirmed however livanova (b)(4) received a test report which confirmed the patient infection with mycobacterium chimaera.A review of the dhr from all six the devices that were used at that time did not identify any deviations or non-conformities relevant to the reported issue.Device not returned.

• 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: 7103563
• MDR Text Key: 94342310
• Report Number: 9611109-2017-00991
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• 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): Death
• Patient Age: 71 YR