MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND 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

There was no known patient involvement. Serial number is unknown. This information will be provided in a supplemental report if made available. 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. Through 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 in use at the hospital are very clean and there is no sign of biofilm. The devices are located inside the operating theatre during use. Two (2) over five (5) devices which were in use at the hospital resulted to be contaminated. Only one serial number has been provided ((b)(4)). The second serial number remains unknown ((b)(4)) as well as the type of contamination. The serial number of the device used for the two surgeries subject of this specific report remains unknown. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that a male patient undergone two cardiac surgeries and a heater-cooler system 3t was used. The first on (b)(6) 2019 and the second on (b)(6) 2019. Reportedly, the patient showed signs of infection and cultures showed m. Chimaera confirmed by testing at another facility ((b)(6) hospital). Patient reported that he contracted infection during one or both of his surgeries. Patient is under antibiotic treatment.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• MDR Report Key: 11322367
• MDR Text Key: 234493883
• Report Number: 1718850-2021-01021
• 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
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 01/13/2021
• Event Location: No Information
• Date Manufacturer Received: 01/13/2021
• 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

Patient Treatment Data

Date Received: 02/12/2021 Patient Sequence Number: 1