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 Type  malfunction  

Event Description

Livanova deutschland received a report that a heater-coolersystem 3t was contamination by mnt chimaera.There is no patient involvement.

Manufacturer Narrative

There was no known patient involvement.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).Correction/removal number: 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 italy.According to customer, the device is cleaned and maintained regularly per the instruction for use and that it was placed outside the operating theater.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: through follow-up communication under a previous complaint from the same hospital, livanova learned that the device was cleaned regularly as per the instructions for use and the water quality monitoring was applied and the h2o2 was checked every day.A disposable pall-aquasafe water filter with an 0.2 m membrane for tap water or an equivalent performance filter is used and when the device is not used, it is stored drained.Reusable blankets are not used.Before initial operation and storing the heater-cooler, the surfaces and water circuits are disinfected and the device surfaces also after every operation.3t aerosol collection set is replaced after the allowed use period.The device is placed inside the operation theatre during use, with the fan positioned opposite to the patient; the estimated distance between the surgery field and the device is two (2) meters.No evident or systematic deviation from device instruction for use could be identified in this specific case.However, the source of contamination is most likely related to location where device is used/stored.

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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16042368
• MDR Text Key: 308543138
• Report Number: 9611109-2022-00688
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2017
• 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