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

Model Number 16-02-80

Device Problem Failure to Pump (1502)

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

Event Type  malfunction  

Event Description

Livanova deutschland received a report that patient pump 2 of the heater-cooler system 3t was not working.The issue was detected during priming.There was no patient involvement.

Manufacturer Narrative

There was no 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).Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in lausanne, switzerland.Through follow-up communication, livanova learned that the event occurred in priming and two (2) error messages related to stirrer motor and patient pump 1 were seen by the customer.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the two (2) reported error messages.However, during troubleshooting, it was detected that patient pump 2 was not working and would not spin.In order to solve the issue, the patient pump 2 was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Based on the available information and taking into account investigation results for similar complaints, the most likely root cause of the reported issue could be associated to pump motor bearing damaged by the corrosion, which consequently does not allow the motor shaft to rotate.Possible causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.Causes related to environmental conditions.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 16681629
• MDR Text Key: 312692835
• Report Number: 9611109-2023-00146
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• 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
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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