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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova deutschland 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 blackpool, united kingdom.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.There was no patient injury.

Manufacturer Narrative

Livanova received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chimaera.There was no patient injury.Through follow-up communication, livanova learned that, following reporting this mycobacterium positive result, the customer had 2 negative ones on this machine.Moreover, since the device is 10 years old, in case of another positive result the customer is evaluating a replacement with consequent scrap of this unit.At the time of complaint closure there is no evidence that the customer is available to provide requested information about water check activities to be performed and how the ifu is followed.Based on investigations of similar complaints and without information received, there was no evidence that the source of contamination is in the heater cooler itself and could be most likely related to location where device is used/stored and/or due to the fact that the ifu could be not followed correctly.If any additional information pertinent to the reported event and impacting the investigation results is received, this complaint file will updated.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

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
• 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: 15630135
• MDR Text Key: 302081681
• Report Number: 9611109-2022-00530
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2012
• 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