MAUDE Adverse Event Report: LIVANOVA DEUSTCHLAND 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

Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Based on the information provided the reported device serial number cannot be involved in 2014 surgery since it was manufactured in 2016.Livanova requested additional information to the customer and clarification is still pending.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 medwatch report mw5098577 report that a patient presented at the hospital on 2020 with malaise and fever and was found positive to mycobacterium chimaera.The patient has history of cardiac surgery on 2014 and a heater-cooler was used.The patient underwent a second surgery on 2019 and reportedly the same device was used.

Event Description

See initial report.

Manufacturer Narrative

H.10: as reported in the initial report, the serial number of device was not stated within the report.It was unclear if device used during 2014 surgery and 2019 surgery is the same (b4 indicated for both surgeries).A second medwatch mw5098576 report was submitted for this customer facility and comparing both reports, it reasonable to assume that the serial number of the device used in 2019 surgery is 16s17157.However, even if from the event description provided in this specific case, it seems that device used in 2014 and 2019 is the same, this is not possible since 16s17157 was manufactured in 2016.Thus, it is reasonable to assume that the same serial number 16s17157 was used for 2019 surgery on this patient and also in another surgery on another patient captured under mw5098576 (as stated within the mw report, the device was used also on a second patient).The device used in 2014 for this patient remains unknown.A device (16s17157) service history review has been performed and identified that the unit was manufactured in 2016.The device 16s17157 was not yet upgraded with vacuum and sealing kit at the time of 2019 surgery.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Through follow-up communication livanova learned that the device was cleaned regularly as per instruction for use and that it was placed inside the operating theater with the fan directed away from the surgical field.No additional information is currently available on this specific case and the root cause could not be determined.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUSTCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11314947
• MDR Text Key: 234212329
• Report Number: 1718850-2021-01018
• 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
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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 Model Number: 16-02-85
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/11/2022
• Device Age: 4 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other