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

Model Number 16-02-80

Device Problem Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2020

Event Type  malfunction  

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 (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and confirmed the reported issue.The patient pump was found to be blocked thus it was replaced.The issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error code associated to a patient pump during priming.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H10: the most likely root cause of the reported event is reasonably assigned to environmental conditions in which the pump worked.Indeed, water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase may have caused its failure.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10762240
• MDR Text Key: 213890271
• Report Number: 9611109-2020-00613
• 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: 10/27/2020

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: 10/02/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/14/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1