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 Type  Death  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova will attempt to retrieve additional information.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 report that a (b)(6) years old female patient underwent cardiac surgery in 2015 for supra-aortic stenosis.In (b)(6) 2015 she had a procedure with mechanical valve prosthesis insertion due to residual of aortic stenosis/regurgitation associated with an aortic pseudoaneurysm.Within the provided documentation it is stated that in (b)(6) 2020 she was re-admitted in hospital with weight loss, splenomegaly, increased transaminases and choroiditis.Mycobacteria were detected in blood and antimicrobial therapy was intensified.On (b)(6) 2020 she presented to her weekly plasmapheresis and was admitted in hospital because of significant weight loss.Ng tube feeding was started.She had a seizure following intraparenchymal brain hemorrhage.Her antibiotics were broadened and anticoagulation was stopped.On (b)(6) 2020 she had an episode of alterated responsiveness and a seizure-like event following a new left superior temporal gyral hemorrhage.The following morning she had a new posterior fossa hemorrhage and an increase in the size of the supratentorial intraparenchymal hematomas.Examination of resected aortic tissue revealed disseminated mycobacterium chimaera infection.Therefore, antimicrobial treatment was initiated and continued intermittently due to her intolerance to microbial antibiotics.The patient condition worsened until (b)(6) 2021 when she died.According to medical evaluation provided in the documentation, the cause of death was hemorrhagic central nervous system complications of disseminated mycobacterium chimaera infection.

Manufacturer Narrative

H.10: further analysis of autopsy documentation revealed that the patient underwent a second surgery in (b)(6) 2017.Surgical pathological examination of resected aortic tissue revealed the presence of acid fast bacilli with subsequent diagnosis of mycobacterium chimaera infection in 2017.The diagnosis was confirmed along 2020 as specified in b.5 section of the initial report.Within the documentation provided, it was not specified where both surgeries (in 2015 and 2017) took place.Only the name of the hospital where there was the last hospitalization and the autopsy is known: the hospital for sick children in (b)(6), canada.It is unclear if the surgeries took place at this same hospital.No dhr and shr could be performed since no serial number wad provided.In 2015 no heater-cooler device was upgraded with vacuum and sealing kit since the design change was implemented in 2017.No further investigation is possible and the root cause of the reported event could not be determined.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
• 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: 12711325
• MDR Text Key: 278791153
• Report Number: 9611109-2021-00611
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191402
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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?: No
• Date Manufacturer Received: 11/28/2021
• Was Device Evaluated by Manufacturer?: No
• 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