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

Model Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 05/24/2019

Event Type  Injury  

Event Description

Livanova received report that a female patient underwent cardiac surgery for replacement of aortic valve and root in (b)(6) 2019.Mycobacterium chimaera infection was diagnosed in (b)(6) 2021.The patient is living and was subjected to antimicrobial therapy and re-surgery.The serial number of the heater cooler 3t used during surgery is unknown.

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).Patient has history of heart surgeries/medical procedures before and after diagnosis of bacterial infection.Documentation has been shared with livanova and analysis is ongoing.Within the document shared with livanova, it was stated that upon information and belief, the heater cooler 3t used during the surgery in may 2019 was not upgraded with vacuum and sealing kit.Additional details will be communicated once the analysis of the provided documentation is completed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: analysis of the documentation shared with livanova has been completed.The results are as follows: on (b)(6) 2019 the female patient underwent surgery at (b)(6) hospital to remove a stenotic mitral bioprosthesis which was placed during patient¿s first surgery at (b)(6) medical center in on (b)(6) 2016 and for the insertion of a biocor size#3 mitral prosthesis.Upon information and belief, a heater cooler 3t was used during on (b)(6) 2019 surgery and this device had no vacuum and sealing kit installed.Aside from a transient heart block, which was treated postoperatively, patient¿s surgery appeared to be a complete success and recuperation seemed to go well.On (b)(6) 2019 patient¿s baseline weight was documented at 200 pounds.In (b)(6) 2020, patient developed lower abdominal and vaginal pain.Patient was diagnosed with bacterial vaginosis and a urinary tract infection.The patient received and completed a couple courses of oral antimicrobial therapy.On (b)(6) 2021 the patient was diagnosed with sinusitis with bilateral earaches and was treated with antibiotics and eardrops.On (b)(6) 2021 the patient presented to (b)(6) medical center for cardiology follow-up appointment and underwent an echocardiogram which revealed valvular vegetation.Patient was diagnosed with prosthetic valve endocarditis.A picc line was inserted and patient was started on iv cefepime and daptomycin, oral doxycycline and fluconazole.On (b)(6) 2021 at (b)(6) medical center, the patient underwent a transesophageal echo which showed 2 mobile vegetations on mitral valve leaflets, vegetation present along anteromedial aspect of mitral annulus.The course of antimicrobial therapy was continued.During that visit, the patient was recorded at 172 pounds.During the therapy there was no change in the symptoms.On (b)(6) 2021 the patient presented to (b)(6) clinic for further testing due to diagnosis of endocarditis.After undergoing a coronary angiogram, another heart surgery was recommended due to the infected valve.On (b)(6) 2021 the patient underwent an extraction of an infected mandibular tooth which was required prior to the upcoming heart surgery.On (b)(6) 2021 patient underwent another mitral valve replacement at (b)(6) clinic.Operation findings included a grossly infected mitral valve and a sample of the valve tissue was sent for culture at the university of washington medical center.The patient developed a postoperative arrhythmia which led to the need for the placement of a permanent pacemaker.On (b)(6) 2021 patient was discharged from (b)(6) clinic and returned to home.On (b)(6) , the (b)(6) medical center sent back the culture of the explanted valve tissue as stating ¿mycobacterium chimaera or mycobacterium intracellulare or mycobacterium paraintracellulare dna detected with 16s rrna gene primer set.Testing method does not distinguish between these organisms¿.On (b)(6) 2021 the (b)(6) medical center sent the final culture which confirmed the presence of mycobacterium chimaera.On (b)(6) 2021 the patient presented to university of tennessee medical center with stroke-like symptoms, subretinal abscess, gi bleed and anemia.A stroke was ruled out and patient diagnoses list included ¿disseminated myco infection¿.At this point, the course of antimicrobial therapy was discontinued.On (b)(6) 2021 patient was started on an empiric mycobacterium therapy course (azitromycin, ethambunol, amikacin and rifampin).However, shortly after starting these treatments, the patient stopped taking rifampin as she could no longer tolerate it.On (b)(6) 2021 patient was once again admitted to (b)(6) medical center for recurring falls, gi bleed, new splenic infarct thought to be septic emboli and new systolic ejection murmur.Patient also expresses having issues with confusion.At this time, amikacin was discontinued due to new hearing loss/tinnitus and balance issues.During week stay at the hospital, the patient¿s health care providers expressed concern for a continued dissemination of mycobacterium infection and endocarditis but determined that she was ineligible for further cardiac surgery.Because patient¿s health care providers could offer no additional interventions for her conditions, she was discharged with palliative care on (b)(6) 2021.On (b)(6) 2021 patient¿s weight was recorded at 151 pounds and decision was made to discontinue her empiric mycobacterium therapy entirely due to their intolerable side effects.Reportedly, ntm infection has resulted in significant injury to the patient, including but not limited to a persistent and active ntm infection that has spread throughout her body.The infection was reported to be terminal.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: from installed base analysis, it was found that the 19 devices are currently in use at the customer site.Of the 19 devices potentially involved in the incident, no one was upgraded with vacuum and sealing kit at the time of may 2019 surgery.A complaint database analysis revealed no previous device contamination complaints submitted by this hospital prior to the may 2019 surgery.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

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
• MDR Report Key: 14042884
• MDR Text Key: 288985047
• Report Number: 1718850-2022-01005
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2022
• Event Location: Hospital
• Date Manufacturer Received: 06/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening