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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Death (1802)

Event Date 07/03/2018

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, 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).Livanova initiated an investigation.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 stating that a patient undergone a cardiac surgery on (b)(6) 2014, he was infected by mycobacterium chimaera and died on (b)(6) 2018.In (b)(6) 2018, the patient experienced persistent high fever, changes in liver and kidney function.He was first hospitalized at the "(b)(6)" in (b)(6) from (b)(6) 2018 until (b)(6) 2018 and then at the "(b)(6)" in (b)(6) until (b)(6) 2018.The patient was again hospitalized on (b)(6) 2018 until he died on (b)(6) 2018.

Manufacturer Narrative

H.10: through follow-up communication under a device contamination case from the same hospital livanova learned that the devices were cleaned regularly per the instruction for use and that they were placed outside the operating theatre during use.However, the cleaning practise in place at the time of the surgery remain unknown as well as the serial number of the device used during the surgery.A complaints database check revealed that no contamination complaints were received from this clinic until the first submitted in 2018.The devices currently in use at the hospital are the followings: (b)(6).Five (5) devices manufactured after the surgery in 2014 can be excluded from the ones being in use since then.The possibly involved device are the followings: (b)(6) (both manufactured on 16.09.2009).A service history check has been performed for this devices and did not identify any deviations relevant to the reported event in 2014.The root cause remains unknown.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: livanova retrieved additional information through follow-up communication with the customer.The customer did not track serial number used for the surgery, however it was possible to trace the serial numbers of the machines used at the customer facility at the time of the event which are (b)(6) as anticipated in the previous supplemental report and now confirmed by the customer.In addition, the customer communicated that: - the device was cleaned in accordance with the instructions for use valid at the time of the intervention.- the fan of the device was oriented away from the surgical field.- single-patient heated mattresses were sometimes used in the past and reportedly the instructions for use were always followed.- microbial sampling and testing were conducted.Results have not been shared with livanova and there is no evidence that the devices were found to be contaminated.- the washing and disinfection mechanisms have always occurred in accordance with the manufacturer's instructions, as documented by the registers of the operating department.The protocols were modified in 2015, in full application of the contents of field safety notice of (b)(6) 2015.They were then confirmed following the second field safety notice of (b)(6) 2016.- until 2016, the water destined for the heater coolers was treated with a disinfectant indicated by the manufacturer; since 2016 a pal filter was used on the terminal dedicated to the heater coolers for filling device tanks and replaced according to the periodicity indicated by the manufacturer.- the sampling and testing of the water sources were not carried out at the customer site because they were not required by the regulations of the time.- the patients did not die at the customer facility therefore the customer does not have death certificate and the facility is not aware of the primary and secondary cause of death.- following the discovery of infections the devices were no longer used, taken out of operation and put under seal.Reportedly the customer observed the national survey on the incidence of mycobacterium chimaera prosthetic infections associated with the use of heat coolers in cardiac surgery, the field safety notice issued by livanova and ecdc guidelines.Since (b)(6) 2009 (when both above mentioned device were installed) the following measures were taken: ¿ immediate adoption of the maintenance and disinfection procedure, in compliance with the manufacturer's instructions.¿ following the first notice, (b)(6) hospital proceeded to apply the new disinfection methods, contained in the notice itself and in the new edition of the instruction for use in (b)(6) 2015, the customer - increased the frequency of disinfections from biweekly to weekly (as indicated by livanova).- positioned of the machine as far as possible from the operating field and not oriented directly towards the operating field - applied daily replacement of the water in the device tanks.A complaints database review revealed no events of device contamination submitted for the above mentioned serial numbers and based on the collected information there is no evidence that the devices were found to be contaminated.Despite a relationship between the device and the reported adverse event cannot be excluded, no definitive conclusion could be established.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9710607
• MDR Text Key: 179397131
• Report Number: 9611109-2020-00092
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• 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