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 Problem Uveitis (2122)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.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).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).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

Through media monitoring livanova (b)(4) found an article in www.Ilgazzettino.It which is claiming, that a patient has undergone a surgery for an aortic valve replacement in udine in the year 2012.15 months later he developed a fever and has been hospitalized several times, in total three months.The patient experienced an `´uveitis´ and `spleen rupture`.The infection has been confirmed in 2019 when the patient resulted positive to the chimaera.This complaint is on a newspaper article with just the region 'friuli venezia giulia' mentioned, whereas the name of the hospital is not reported in the article.

Manufacturer Narrative

The possibly affected serial number is (b)(6).However, its use at the time of the reported surgery could not be confirmed.Through follow up communication livanova deutschland learned that the center was user of blanket until march 2019, with change of blanket every 14 gg.Now they use only disposable blankets.

Event Description

See initial report.

Manufacturer Narrative

The name of the hospital where the event occured was provided.Through follow up communication, livanova deutschland learned, that the hospital is scrupulously following the cleaning and disinfection procedure as per the instruction for use.The hospital has five (5) heater cooler units in use within the three (3) operation rooms.The serial numbers of the five possibly affected heater cooler units were provided.A review of the dhr of all affected units could not identify any deviations or nonconformities relevant to the issue.

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: 8802008
• MDR Text Key: 151579921
• Report Number: 9611109-2019-00552
• 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,literatur
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• 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
• Date Manufacturer Received: 10/31/2019
• 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