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

Model Number 16-02-80

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

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.The service representative was able to confirm the reported issue and traced the failure to a defective processor board.The technician replaced the board to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Evaluated on site by livanova rep.

Event Description

Livanova (b)(4) received a report that the control panel on the patient side of a heater-cooler system 3t did not work during priming.There was no patient involvement.

Manufacturer Narrative

The board was returned for further investigation.During the evaluation the issue could not be reproduced after the software was re-installed on the board.The board worked according the specification.Therefore no specific root cause could be determined.

Event Description

See initial.

• Brand Name: HEATER.-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 7436040
• MDR Text Key: 105776311
• Report Number: 9611109-2018-00895
• 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: 01/03/2019

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: 03/20/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1