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

Catalog Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 02/14/2017

Event Type  Injury  

Event Description

On april 2022, livanova received a medwatch stating that a patient underwent an aortic valve replacement and repair of aortic aneurysm in february 2017 during which a sorin 3t heater/cooler was used.According to received inforation, the heater-cooler was purchased in 2012 and maintained according to manufacturer's ifu.The unit was not used after july 2018 and was returned to the manufacturer in 2019.In (b)(6) 2022, the patient was diagnosed with a (b)(6).

Manufacturer Narrative

A.1., a.2, a.3.,a.5.Patient information was not provided.D.4.Serial number is unknown.This information will be provided in a supplemental report if made available.H.4.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.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 atlanta, georgia, unites states.Livanova initiated an investigation.A complaints database review revealed other similar events submitted by the same hospital.Based on the event description provided, an analysis of shipping record for the involved customer facility has been conducted.Analysis revealed that six (6) devices were sold in 2012.Serial number are the followings: (b)(6).However, the serial number of the device used during the surgery could not be identified.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

Customer information have been added to the dedicated e section.H.10: based on the surgery date ((b)(6) 2017), it is possible to determine that the heater cooler used during the procedure was not equipped with the vacuum and sealing kit.Livanova performed multiple attempts in order to retrieve additional information regarding the reported event but the customer did not reply.No additional information is currently available on this specific case and a relationship between the device and the reported adverse event could not be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial 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: 14239694
• MDR Text Key: 290466636
• Report Number: 1718850-2022-01006
• 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,Followup,Followup
• Report Date: 03/21/2022,04/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-02-85
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2022
• Distributor Facility Aware Date: 07/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 08/10/2022
• Supplement Dates FDA Received: 07/07/2022; 08/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1