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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fatigue (1849); Fever (1858)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided.Patient weight was not provided.The model and serial number are unknown.This information will be provided in a supplemental report if made available.As the model number is unknown, the 510(k) number could not be determined.However, it is likely the device is model number 16-02-80, which is not distributed in the usa, but 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) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).(b)(4).At this time, it is unknown if the device utilized during surgery has tested positive for contamination, or if the use of the device is related in any way to the reported patient infection.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) identified an article indicating that a patient reported fever, cough and fatigue in (b)(6) 2016 after undergoing a bio-prosthetic mitral valve replacement for severe sterno-regurgitation in (b)(6) 2014 without complication.A heater-cooler system 3t was used during the surgery.Test of blood and bone specimens from the patient revealed a mycobacterium chimaera infection.The facility performed a surgical treatment (percutaneous vertebroplasty) and, following a complete anti-biogram, the patient showed significant clinical improvement.Article reference: le infezioni in medicina, n.3, 267-269, 2017."disseminated mycobacterium chimaera infection after open heart surgery in an (b)(6) woman: a case report and a review of the literature.".

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Follow up communication with the author of this article revealed that an heater cooler was used during the procedure.No device information was provided in the article, and it could not be retrieved through follow up communication.A review of existing complaints did not identify any event that matched the description provided in the user report.No further investigation is possible.In the event of receipt of new information, a supplemental report will be provided.Event of patient contamination with (b)(6) are known to livanova, and corrective actions are in progress for this issue.Device not returned.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6990264
• MDR Text Key: 90667636
• Report Number: 9611109-2017-00875
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 70 YR