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

Model Number 16-02-80

Device Problem Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 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: k052601).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 replaced the patient pump 2.The issue could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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.

Event Description

Livanova (b)(4) received a report of a heater-cooler system 3t with patient pump not working after cleaning procedure.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: the root cause of the issue was an overfilling of the tanks by the user.This led to water ingress in the pumps circuit boards and causing the reported failure.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9514793
• MDR Text Key: 174602170
• Report Number: 9611109-2019-00998
• 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: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• 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
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1