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 06/19/2017

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Livanova deutschland 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).Livanova (b)(4) initiated an investigation.As previously reported in the importer medwatch # (b)(4) and the manufacturer medwatch # mw-007589, through follow-up communication with the chief perfusionist livanova (b)(4) 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 of 8 patients infected with mycobacterium chimaera.The importer medwatch # (b)(4) and the manufacturer medwatch # mw-007589 already submitted.This report captures one of the mentioned patient infections.Following to primary diagnosis of aortic valve insufficiency, a patient undergone cardiac surgery on (b)(6) 2017.An heater-cooler system 3t was used.The same day (b)(6) 2017, the patient was confirmed to be infected with mycobacterium avium and mycobacterium chimaera was identified.The patient was treated and is currently doing well.

Manufacturer Narrative

A service history review reveals that the unit supposed to be used for the surgery was installed at the clinic on (b)(6) 2017 which is later than the surgery date reported.Moreover, a complaint database analysis revealed that no device contamination complaint was previously submitted from the hospital for this specific device.This very likely excludes the complained device to be the cause of the incident.

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.

• 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: 9646579
• MDR Text Key: 183734807
• Report Number: 1718850-2020-00008
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• 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: 07/01/2020
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1