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

Catalog Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 04/05/2019

Event Type  Injury  

Event Description

Livanova received report of an alleged m.Chimaera infection, no information about date or fact of diagnosis a male patient on (b)(6) 2019 underwent an open-chest cardiac surgical procedure (replacement of aortic root and valve) with cardiopulmonary bypass using a livanova heater/cooler 3t device at (b)(6) hospital.At that time the hospital did not follow the specific recommendations by the fda to minimize or eliminate the unreasonable risk of airbone transmission of ntm / m.Chimaera to patients undergoing open-chest cardiac surgical procedures.On (b)(6) 2020, the hc 3t devices used in this hospital were replaced with new version of 3t (vacuum and sealing upgrade).From (b)(6) 2021 the patient has had clinical worsening due to the recurrence of certain symptoms (e.G.Weight loss, weakness, fatigue, cough, abdominal pain, granulomatous hepatitis, brain fogginess).On (b)(6) 2021 he was diagnosed with chorioretinitis resulting from disseminated m.Chimaera infection; aortic valve was removed and positive culture for m.Chimaera was found in aortic tissue and valve itself.Patient is living.

Manufacturer Narrative

Patient id, age, gender and ethnicity: patient information was not provided 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.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 deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.A complaints database review revealed other similar events submitted by the same hospital.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: through follow-up communication with the chief perfusionist under previous cases from the same hospital, livanova deutschland 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 theater during use.The result of microbial sampling performed at customer site revealed that two devices in use at the hospital were found to be contaminated.It is not possible to determine if the device used for this specific surgery was one of the two devices confirmed to be contaminated and if the device used was actually contaminated at the time of surgery.No dhr and shr could be performed since no serial number was provided.No device, between the ones in use at the hospital, was upgraded with vacuum and sealing kit at the time of the surgery on (b)(6) 2019.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; lindberghstrasse 25; munich
• MDR Report Key: 13116608
• MDR Text Key: 288293443
• Report Number: 1718850-2021-01223
• 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: 12/01/2021,12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-02-85
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2021
• Date Manufacturer Received: 03/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male