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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 07/08/2017

Event Type  Death  

Event Description

Livanova received report that a patient underwent cardiac surgery on (b)(6) 2017 and a heater cooler 3t device was used.The surgery was successful and the patient was included in the list for heart transplant.The patient remained stable until second half of 2019 when fatigue and weight loss presented.In march 2020, endocarditis was diagnosed and infection with m.Chimaera was confirmed.Antibiotic therapy was initiated.On april 17, 2020 the patient underwent heart transplant surgery.The day after the transplant, antibiotic therapy was modified with additional drugs due to the presence of staphylococcus.On (b)(6) 2020 the patient resulted negative to staphylococcus and still positive to m.Chimaera.On (b)(6) 2020 the patient passed away reportedly due to m.Chimaera infection, severe heart failure, cardiac transplant.

Manufacturer Narrative

Patient information was not provided.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Correction/removal number: livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is (b)(4).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Detailed documentation was shared with livanova and analysis revealed the following: on february, 2017 the male patient went to the (b)(6) hospital for severe anginal pain, diagnosis: anterolateral myocardial infarction.First surgery was done on (b)(6), 2017 at (b)(6) hospital for angioplasty (ptca) on the distal right coronary artery with medicated stent.For the period between april and june 2014, the patient underwent three (3) hospitalizations at (b)(6) hospital: one of those was related to the defibrillator implantation (icd) in prevention, performed on (b)(6) 2017.Second surgery was done on (b)(6) 2017: patient underwent lvad (left ventricular assist-device) implantation heartmate 3-type at (b)(6) hospital.Serial number of device used is (b)(4); patient pre-operative examinations (blood cultures performed on (b)(6) 2017) for the research of atypical non-tuberculous mycobacteria with negative results.Good and stable condition of the patient until the end of summer 2019.Medical check dated (b)(6) 2019 revealed onset of asthenia, heaviness in the lower limbs, pancytopenia.On (b)(6) 2019 the patient was hospitalized for worsening of symptoms (e.G.Severe weight loss).Medical check dated (b)(6) 2020 revealed worsening of symptoms and provision for sampling for research of m.Chimaera.On (b)(6) 2020 the patient was hospitalized at (b)(6) hospital for a positive response from m.Chimaera, diagnosed with bacterial endocarditis.He started antibiotic therapy.At the end of march 2020 medical report of m.Chimaera found also on bone marrow.On (b)(6) 2020 the patient underwent heart transplantation and removal of devices (lvad and icd) as the only possibility of eradication of m.Chimaera infection.Blood cultures of (b)(6) 2020 were still positive for m.Chimaera and antibiotic therapy started.On (b)(6) 2020 the patient was transferred to intensive care for respiratory acidosis.In july 2020 the patient began dialysis following medical evaluation.On (b)(6) 2020 following an eye examination the patient was diagnosed with chorioretinitis, compatible with m.Chimaera infection.On (b)(6) 2020 following the serious conditions, the patient was transferred to the (b)(6) hospital in nephrology department.On (b)(6) 2020 the patient died of severe m.Chimaera sepsis, heart failure and heart transplant.As per what was reported in the provided documentation, since blood cultures of the patient were negative until the second surgery (performed on (b)(6) 2017), the patient got infected with m.Chimaera during surgery on (b)(6) 2017.Within the provided document, some details of device cleaning and maintenance practice in place at (b)(6) hospital are stated.It is specified that, in addition to periodic environmental sampling: some changes in the length of the tubings were made to move the devices further away from the patients.However, it was found that it was impossible to move them outside the operating room.Softened water is used for the daily filling of the devices, taken from a dedicated tap where a terminal filter has been placed and replaced monthly.H2o2 is added to the water.Disinfection processes were followed according to device instruction for use.The device used during the surgery (sn (b)(4)) was charged with the related maintenance with a full risk contract.This device was subjected to sampling on (b)(6) 2017 with negative results for the culture of m.Chimaera.Extraordinary disinfection intervention on all machines in service was carried out on (b)(6) 2017.In the months of june and july 2017 the water inserted in the device, used in the operation in question, was promptly changed every day of use with the addition of disinfectant every two weeks.In august 2017 this device was removed from service.Review of device service history revealed that the device was not yet upgraded with vacuum and sealing at the time of surgery ((b)(6) 2017) and that it was upgraded on (b)(6) 2017.Complaints database review revealed no device contamination complaints submitted for this device.From follow up communication under device contamination case from the same hospital back in 2017, livanova learned that the disinfection procedure was not performed according to the instructions for use.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

H10: a review of the device history record (dhr) could not identify any deviations or non-conformities relevant to the issue.Through follow-up communication with the customer, livanova learned that: confirmation that the involved patient underwent cardiac surgery on (b)(6) 2017; a water sampling was carried out on (b)(6) 2017 on the heater cooler 3t system used during the surgery, with negative results; no further water samplings on the device are available, since the unit was put out of use in august 2017 due to obsolescence and replacement with similar new device; in 2017, 10 water samplings were carried out on all active livanova heater cooler 3t systems, all with negative results.On (b)(6) 2017 sampling was carried out on the water withdrawal points, equipped with an anti-bacterial filter replaced on a monthly basis, with negative results.In (b)(6) 2016, a positive result was found on another 3t livanova device, promptly put out of use and sent to the parent company for a deep disinfection procedure (complaint ref.#(b)(4)); water filters used were pall-aquasafe 0.2 micron type; at time of the surgery (2017), for technical reasons, it had not yet been possible to position the devices outside the operating theaters.The tubings had been lengthened up to the maximum allowed (5 meters) and positioned with the air outlet fan facing the room wall near the air evacuation mouth.In addition, a deflector was applied to direct the airflow downwards towards the outgoing air intake.The distance between the patient's chest and the fan was about four (4) meters.Based on the above, at the time of surgery the hospital followed correctly the device instructions for use and no positive mycobacterium chimaera result was detected.A relationship between device and reported event could not be determined.

• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15804222
• MDR Text Key: 303713723
• Report Number: 9611109-2022-00591
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• 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: 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2003
• 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): Other; Death