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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

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

Event Type  Death  

Manufacturer Narrative

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) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in an unknown city, most likely in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Through literature review livanova became aware of a (b)(6) years old male patient who undergone first cardiac surgery in 2004 outside of the facility stated in the article (b)(6) clinic).In 2011 the patient undergone another surgery for aortic valve replacement.Reportedly, no bacterial infection was suspected at the time of the surgery.He never fully recovered and presented notable fatigue, pancytopenia and liver disfuction.In 2014 he undergone cardiac surgery for the third time.It remain unclear from the article in which hospital the surgeries took place.Intraoperativly, he was found to have an aortic root abscess.Mycobacterium avium intracellulare grew from valve tissue several weeks after the surgery and also in pleaural fluid cultures aspirated a few days before the repeat surgery.The patient was started on a regimen of antibiotics in (b)(6) 2014.Twelve (12) months after his 2014 surgery he experienced progressive systemic symptoms such as fever, chills and night sweats.Acid-fast-bacilli test on bone marrow was negative.Despite medical therapy, the patient worsened.In (b)(6) 2015, the aortic root fluid cultures redemonstrated mycobacterium avium intracellulare.He was then transferred to (b)(6) clinic for further management where the m.Avium intracellulare was later specified as m.Chimaera.Per the patient's wishes, he returned to a facility closer to his home and passed away several months later.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• MDR Report Key: 10199501
• MDR Text Key: 196557419
• Report Number: 1718850-2020-01099
• 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
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2020
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death