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

Model Number 16-02-95

Device Problem Device Alarm System (1012)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error code during procedure.Therefore, the customer switched to another device.After the procedure was completed, the customer tried to reproduce the error, but the error did not recur.There was no report of patient injury.

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-95 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 (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).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

H.10: a livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The temperature sensor have been calibrated as precaution.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

Event Description

See initial report.

Manufacturer Narrative

H.10: the error reported by the customer remains unknown since the customer did not remember the code and no error could be reproduced during service activity.No additional information is available on this specific case and no further investigation is possible.Thus, the root cause could not be determined.No further complaint on this unit/ issue has been received up to date thus it is reasonable to assume that the error was temporary and did not recur.

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: 13079668
• MDR Text Key: 283841131
• Report Number: 9611109-2021-00724
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2021

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: 16-02-95
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 12/17/2021; 01/24/2022
• Supplement Dates FDA Received: 01/13/2022; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1