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

Model Number 16-02-85

Device Problem Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.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 that a heater-cooler system 3t displayed an error code during setup.No information about which side the error code was displayed.It can't be excluded that the reported error occurred on the patient side and therefore associated to a stirrer motor malfunction.There was no patient involvement.

Manufacturer Narrative

H.10: livanova received the information that the error code was associated to a patient pump malfunction.The service technician in charge for the activity could confirm the reported issue.He traced the failure back to the patient pump1.He replaced the pump and decided to replace also the distribution board as precaution since the defective pump could have caused damages to the board.The problem was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause of the reported malfunction is a defective electronics of the patient pump.

Event Description

See initial report.

• 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: 9764318
• MDR Text Key: 196775772
• Report Number: 9611109-2020-00149
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K052601
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1