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

Catalog Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Livanova received report that a 58 years old male patient underwent cardiac surgery on (b)(6) 2022 and a heater cooler system 3t was used.The patient was found to be infected with mycobacterium fortuitum.The patient underwent surgical revision on (b)(6) 2022 and antibiotic treatment (tienam + amiklin + levofloxacin) was initiated.

Manufacturer Narrative

The serial number of the possibly involved devices are (b)(4) and (b)(4).This information will be provided in a supplemental report if made available.Udis are ((b)(4) and (b)(4) respectively.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Device manufacture date: the serial number of the possibly involved devices are (b)(4) and (b)(4).This information will be provided in a supplemental report if made available.The manufacturing dates are 23 april 2018 and 02 may 2018 respectively.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow-up communication with the customer livanova collected the following information: the laboratory test report of water sampling performed on the device are not yet available; reportedly, device water samples were sent for analysis and not yet received thus it is still unknown if the device is contaminated or not; no other devices/surfaces in the or/icu were tested in order to verify if contaminated and in order to identify the source of contamination; no microbial test was performed on the sink water; the contamination source has not been investigated at the customer facility.In addition, it was communicated by the customer that device instruction for use are not followed in terms of cleaning and maintenance of water quality.In detail, it was reported that: the device was not cleaned regularly as required by the instruction for use; the customer uses re-usable blankets which can be a potential source of contamination; water quality monitoring (hpc and ntm test) is performed once per year; hydrogen peroxide h2o2 level daily check as required by ifu is not performed; prior to initial operation and prior to storing the heater-cooler, the surfaces are not disinfected; heater-cooler water circuits are not disinfected prior device storage.Moreover, an anios tap water filter is used and replaced each 30 days.Verification of this being equivalent to the pal-aquasafe 0.2 ¿m (required by device ifu) is ongoing.Reportedly the device is used inside the operating theater with the fan directed away from the patient and at an estimated distance of 2 meters from the surgery field.During the surgery the device was reported to have been operated in connection to a vacuum source and the vacuum was applied until patient left the operating room.During follow up with the customer it was highlighted their cleaning and monitoring protocols do not respect livanova ifu.Activities to address this are on-going.Mycobacterium fortuitum is a rapidly growing nontuberculous mycobacterium (ntm), it is classified in the runyon group iv.Source of contamination of this type of bacteria can be everywhere, its distribution is probably worldwide.There is no literature link between contamination and 3t device.Cdc did not report any events with type of bacteria.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Has stated in the initial report, customer reported that an anios filter was used for tap water and that it was replaced each 30 days replacement.The specific model of filter was not specified by the customer.However, based on the anios catalog product it is reasonable to assume that they use a tap water filter with 0.2 m porosity which is equivalent to pall-aquasafe water filter with an 0.2 m membrane recommended in the device instruction for use.As per what reported in the previous supplemental report, the devices in use at the hospital were found to be contaminated with mycobacterium gordonae which is different from the bacterium found in the patient (mycobacterium fortuitum).Both device contamination events, unrelated to this specific patient infection event, are reported under the following references: - manufacturer report number 9611109-2022-00361.- manufacturer report number 9611109-2022-00570.

Event Description

See initial report.

Manufacturer Narrative

H.10: livanova representative reviewed the cleaning and maintenance process of devices with the head of the patient safety quality department and the head of infectious risk management department of the customer.A review of the process was also done with one of the perfusionist to ensure the customer adheres to livanova device instruction for use.Through follow-up communication livanova retrieved the laboratory test results of microbial sampling conducted on the potentially involved devices.Results showed that devices were contaminated with mycobacterium gordonae which is different from the bacterium found in the patient (mycobacterium fortuitum).The two different species of bacteria (m.Gordonae and m.Fortuitum) are not in competition and can coexist in the same environment.Based on this and considering that the heater cooler devices were contaminated with m.Gordonae and not with m.Fortuitum found in the patient, it is reasonable to conclude that the source of patient infection (m.Fortuitum) was not device related and any relationship between heater cooler device and the reported event can reasonably be excluded.

Event Description

See initial report.

Manufacturer Narrative

Livanova received report that a patient underwent cardiac surgery on (b)(6), 2022 and a heater cooler system 3t was used.The patient was found to be infected with mycobacterium fortuitum.The patient underwent surgical revision on (b)(6), 2022 and antibiotic treatment was initiated.Through follow up with the customer it was clarified that anios tap water filter is used and replaced each 30 days.The specific model of filter was not specified by the customer.However, based on the anios catalog product it is reasonable to assume that they use a tap water filter with 0.2 m porosity which is equivalent to pall-aquasafe water filter with an 0.2 m membrane recommended in the device instruction for use.The root cause of the patient infection is unknown.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 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: 15110453
• MDR Text Key: 296662131
• Report Number: 9611109-2022-00368
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2023

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 Catalogue Number: 16-02-80
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/14/2022; 10/14/2022; 12/14/2022
• Supplement Dates FDA Received: 10/14/2022; 11/09/2022; 01/11/2023
• 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 Age: 58 YR
• Patient Sex: Male