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 09/24/2019

Event Type  Injury  

Manufacturer Narrative

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).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

A male patient born on (b)(6) undergone a cardiac surgery on (b)(6) 2019.The patient resulted to be infected with m.Avium intracellulare complex.This patient infection was previously reported under importer (b)(4) and manufacturer mw-07589.Following to additional information received from the hospital a patients mapping has been done and separated cases have been created.

Manufacturer Narrative

H.10: 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)(6) which is the device claimed in this specific case.A follow up report for the other cases associated to this specific device has been filed.The second serial number remains unknown as well as the type of contamination.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: livanova became aware that the patient underwent an lvad surgery and started showing signs of infection around early 2020.Cultures were obtained and reportedly confirmed (b)(6) in early (b)(6) 2020.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• 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: 9831317
• MDR Text Key: 183751318
• Report Number: 1718850-2020-01036
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 02/13/2020; 09/29/2021
• Supplement Dates FDA Received: 07/29/2020; 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1