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 Problem Bacterial Infection (1735)

Event Date 09/14/2019

Event Type  Injury  

Event Description

Livanova received report that a male patient underwent cardiac surgery for heart valve replacement on (b)(6) 2019.Approximately 2 years after surgery, signs of infection was alleged with subsequent m.Chimaera diagnosis in (b)(6) 2021.The patient is living and on antibiotics.Reportedly, doctors have recommended another surgery to replace aortic valve and root.In addition, complaint alleges that patient has been told he has significantly reduced life expectancy.The serial number of heater-cooler 3t system used during surgery is unknown.

Manufacturer Narrative

Patient information was not provided.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 deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: from installed base analysis, it was found that the 8 devices are currently in use at the customer site.Service history review revealed that 5 serial number manufactured between 2011 and 2017 are potentially involved in the reported event, while the 3 devices manufactured in 2022 can be excluded.Between the 5 devices potentially involved in the incident (16s12810, 16s13267,16s12809,16s17765,16s17203), no one was upgraded with vacuum and sealing kit at the time of september 2019 surgery; indeed, all 5 devices were upgraded in 2020.A complaint database analysis revealed no previous device contamination complaints submitted by this hospital.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova learned the device serial number which was used during the surgery.Model/serial numbers have been added to the dedicated d.4 section.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

Referring to the device involved (sn: (b)(6)), it was not upgraded with vacuum and sealing kit at the time of (b)(6) 2019 surgery; indeed, it was upgraded in 2020.A complaint database analysis revealed no previous device contamination complaints submitted by this hospital.Despite due diligence performed, no response was received by the customer and no additional information could be retrieved on this specific event.Therefore, no definitive conclusion regarding device and the reported event could be reached.

Event Description

See intial 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 GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 14042864
• MDR Text Key: 288789540
• Report Number: 9611109-2022-00159
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2011
• 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): Life Threatening; Other