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

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Endocarditis (1834)

Event Date 10/03/2014

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement.Model number and serial number are unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacturer 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 (b)(6).Livanova (b)(4) initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

On august 16th, 2019, livanova (b)(4) received a user medwatch report (mw5088766) stating that a female patient had a aortic valve replacement on the (b)(6) 2014 and that a heater-cooler system 3t was used for the procedure.Following to that, the patient was found to be positive to a m.Chimaera infection.The patient was taken back to surgery on 2017 for debridement and sternal wire removal.In the medwatch report hospitalization, required intervention and other serious (important medical event) as event outcome are stated.

Event Description

On (b)(6) 2018 a patient received a perceval pvs23 sutureless aortic heart valve implant as part of an avr.The manufacturer was notified via.The patient tracking system that on (b)(6), 2019 the device was explanted and replaced with a second perceval pvs23.On oct.31, 2019 the manufacturer was notified that the device was explanted due to endocarditis.No further information is available.

Manufacturer Narrative

The manufacturer received information indicating the device was explanted due to endocarditis and that no further information is available.The manufacturing and material records for the perceval heart valve, model#: icv1209 , s/n#: (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model#: icv1209) perceval heart valve at the time of manufacture and release.If an infective microorganism was present on the tissue valve before sterilization, it would be killed very easily by the manufacturers liquid chemical sterilant.The sterilant contains a mixture of glutaraldehyde and alcohol, both of which are highly effective against infectious microorganisms.The manufacturer has validated this liquid chemical sterilization process with spore forming bacillus atrophaeus, which is the most resistant microorganism known for aldehydes.Following routine sterilization, the valves are aseptically packaged in a solution that inhibits growth of microorganisms with steam sterilized closures and jars.The packaging process occurs in a vaporous hydrogen peroxide (vhp) decontaminated isolator; therefore there is no risk of valve contamination post-sterilization.Each closure/jar containing the valve is integrity tested after packaging, thus ensuring a sealed barrier for the product to remain sterile during transport up until the closure/jar is opened.At this time due to the limited information available and unavailability of the device for analysis the root cause leading to the reported endocarditis cannot be determined.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 9019622
• MDR Text Key: 161386905
• Report Number: 1718850-2019-01081
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2019,01/24/2020

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 Expiration Date: 04/12/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/26/2019; 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention