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

Model Number 16-02-82

Device Problem Microbial Contamination of Device (2303)

Patient Problem Respiratory Tract Infection (2420)

Event Type  Death  

Event Description

Livanova received report of an alleged m.Chimaera infection.On (b)(6) 2015, patient was operated for elective valve replacement (open heart surgery) and discharged on (b)(6) 2015.On (b)(6) 2022, result of patient¿s sample taken on (b)(6) 2022 resulted positive to mycobacterium avium complex.On (b)(6) 202s, patient admitted at (b)(6) for altered mental status and fever.Cultures were repeated and confirmed infection to mycobacterium chimaera.On (b)(6) 2022, patient passed away.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided h.10: 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 the unites states livanova initiated an investigation.The present importer medwatch was initially submitted on 19may2023 and resubmitted on 25may2023.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• MDR Report Key: 17000649
• MDR Text Key: 315906776
• Report Number: 1718850-2023-01004
• 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
• Type of Report: Initial
• Report Date: 04/19/2023,05/19/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2023
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male