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  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in the united states.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

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.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• 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: 16962477
• MDR Text Key: 315570871
• Report Number: 9611109-2023-00229
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2012
• 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
• Patient Age: 74 WK
• Patient Sex: Male