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 Date 03/06/2019

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.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 follow-up communication with the chief perfusionist related to previous cases from the same hospital, livanova (b)(4) learned that the water in the heater-cooler systems 3t in use is changed every day and the device 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.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)) and a follow up report for the 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

Livanova (b)(4) received a report that a male patient underwent a cardiac surgery on (b)(6) 2019 and an heater-cooler system 3t was used.The patient was possibly infected with m.Chimaera.However, no information if this was diagnosed has been provided.The patient died on (b)(6) 2020.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 11453833
• MDR Text Key: 238874772
• Report Number: 9611109-2021-00108
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/08/2021

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 Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death