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

Model Number UKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 01/12/2015

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.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 (b)(6).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 (b)(4) received a report that a male patient undergone aortic valve replacement on (b)(6) 2015 and an heater-cooler system 3t was use.The serial number of the device used during surgery is unknown.Reportedly, patient showed signs of infection beginning in (b)(6) 2017 and he continued to experience symptoms throughout 2018 and 2019.Mycobacterium chimaera infection was diagnosed in (b)(6) 2020 and treated with courses of antibiotics.He was unable to undergo a second surgery and passed away (b)(6) 2020.

Event Description

See initial report.

Manufacturer Narrative

H.1 section has been corrected to death and aligned to what reported in b sections.In the initial report the incorrect option was selected.H.10: no dhr and shr could be performed since no serial number was provided.No device, between the ones in use at the hospital, was upgraded with vacuum and sealing kit at the time of the surgery.Complaints database analysis revealed that no previous device contamination complaints have been reported by this hospital.The root cause of the event could not be established.No additional information has been provided for this specific case.If any additional information pertinent to the reported event is received, it will be provided in a supplemental 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: 12006553
• MDR Text Key: 268246899
• Report Number: 9611109-2021-00316
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other