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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Livanova initiated an investigation. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a medwatch importer report (b)(4) stating that in (b)(6) 2017, a patient undergone a cardiac surgery and he was recently identified positive to mycobacterium chimaera. A heater-cooler system 3t was used during the surgery. Within the report are stated other information about the patient that may have influenced the outcome of the event: interstitial pulmonary fibrosis diagnosed around 7 years. He presented to clinic with weight gain, peripheral edema, cough and increased dyspnea on exertion. In the past, he has had prolonged carbon silicon exposure.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9737539
• MDR Text Key: 194012505
• Report Number: 9611109-2020-00119
• 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: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/21/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 16-02-85
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015