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

Model Number 16-02-80

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

The heater-cooler 16-02-80 is not distributed in the usa.However, it is similar to the heater-cooler 16-02-85, which is distributed in the usa (510(k): k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The event occurred in (b)(6).A distributor engineer resolved the issue by replacing the patient pump motor.The pump motor has been requested for return to livanova deutschland for investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error code on the patient side and was noisy during a demo stating that the patient circuit pump was blocked.There was no patient involvement.

Manufacturer Narrative

The pump was returned to livanova (b)(4) for further investigation.During the evaluation it was found that the pump was slightly dirty.Further it was found that the motor had a bearing damaged which led to the reported malfunction.The cause of the residues and mechanical damage has been identified with environmental pollution.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7628402
• MDR Text Key: 112464028
• Report Number: 9611109-2018-01063
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• 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 Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1