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 Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.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.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).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 bordeaux, france.Livanova initiated an investigation.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 an unknown type of mycobacterium.There is no known patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H10: serial number and manufacturer date have been added to the dedicated d4 and h4 sections.Through follow-up communication livanova learned that the device was contaminated with mycobacterium abscessus/chelonae.The laboratory reported confirming the reported contamination was provided to livanova.Reportedly, the device was cleaned as per the instruction for use and was placed inside the operating theater during use with the fan directed opposite to the patient and at an estimated distance of 2-3 meters from the surgery field.The device is not used during week-end and is stored full of water.As per instruction for use, if the device is stored full of water during period of non use, the hydrogen peroxide level (h2o2) must be checked daily.It is unclear from the information provided, if the h2o2 level check is performed as prescribed by the device ifu and this may be a contributing factor to the reported contamination.Based on the current level of information, the exact root cause could not be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11200732
• MDR Text Key: 227726004
• Report Number: 9611109-2021-00032
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1