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 Date 08/11/2019

Event Type  Injury  

Manufacturer Narrative

Partial information about the patient has been provided. Livanova (b)(6) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova (b)(6) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Through further follow-up communication with the chief perfusionist livanova learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry. This is not in alignment with current instruction for use however reportedly the devices are very clean and there is no sign of biofilm. The devices are located inside the operating theatre during use. We are currently waiting to know the result of microbial sampling performed at customer site. Reportedly the tests are still in progress. 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 female patient (date of birth (b)(6)) undergone cardiac surgery on (b)(6) 2019 and an heater-cooler system 3t was used. On (b)(6) 2019 the patient was confirmed to be infected with mycobacterium avium intracellulare complex and mycobacterium chimaera was identified.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9764304
• MDR Text Key: 191169985
• Report Number: 1718850-2020-01019
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

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
• Distributor Facility Aware Date: 07/01/2020
• Event Location: No Information
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage