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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

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

Event Date 02/11/2015

Event Type  Injury  

Manufacturer Narrative

Serial number is unknown.This information will be provided in a supplemental report if made available.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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 (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 patient contamination was reported by the healthcare facility of (b)(6), although the patient underwent the cardiac surgery that potentially exposed her to the bacteria in (b)(6) hospital of (b)(6).Available information are not enough to allow a clear conclusion, but it is likely that the event captured under this report is the same reported under the mdr 9611109-2018-01198.Corrective actions are in progress for this issue.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 patient underwent plastic surgery of the mitral on (b)(6) 2015 at (b)(6).The patient developed an endocarditis with a blood culture which was positivized due to the presence of mycobacteria.It was reported that a heater-cooler system 3t was used during the procedure.

Manufacturer Narrative

Through follow up communication, livanova deutschland learned that no info from the hospital were provided even though requested.Furthermore, livanova deutschland learned that the hospital follows the regional rules so all patients with a surgery made between 2010 and 2018 could obtain information if they call the hospital.From (b)(6) 2018 the 3ts were positioned outside the operation room.The devices are also controlled with monthly microbiological checks, all the times the lab results versus mycobacterium chimaera were negative.A serial number has not been provided.Therefore no dhr review as well as a service history record check could be performed.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8349424
• MDR Text Key: 136504031
• Report Number: 9611109-2019-00084
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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: 16-02-80
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR