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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-cooler system 3t device was found to be contaminated with mycobacterium chelonae both pre (31 cfu/ml) and post-disinfection procedure (12 cfu/ml).The laboratory report confirming the reported contamination has been provided to livanova.The unit has been taken out of service by the customer.There is no report of patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.G.5.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in hudson, florida.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Livanova was informed the 3t heater cooler was taken out of service.Through a subsequent follow up, livanova was informed the device is cleaned regularly according to the instructions for use and it is placed inside the operating room, with the fan positioned opposite to the patient at an estimated distance of about 2 meters from the surgery field.The h2o2 level is daily checked when the device is being used.When the device is not used, it is stored full of water and the h2o2 daily check is not executed during weekends.No patient reusable heating blankets are used by the hospital and the 3t aerosol collection set is replaced after the allowed use period.A disposable pall-aquasafe water filter with a 0.2 m membrane is used for tap water.The livanova device is used in combination with medtronic myeotherb and it is connected through opaque disposable tubing.Based on collected findings, it cannot be excluded that the above deviation from ifu's identified relating to the missed daily check of h2o2 during weekends when the device is stored full of water may have caused or contributed to reported contamination.Livanova has implemented a strategy to progressively decrease the probability of bacteria growth in the hc device by applying multiple measures implemented over the past few years through dedicated capa and a field action.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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18379915
• MDR Text Key: 331383839
• Report Number: 9611109-2023-00646
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2011
• 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