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

Model Number 16-02-85

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2017

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).A livanova field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and traced it back to a faulty patient bridge.Replacing the defective component fixed the issue.Subsequent testing found no further issue and the device was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova technician.

Event Description

Livanova (b)(4) received a report that the heater-cooler system 3t displayed an error message when the patient pump was turned on during setup.There was no patient involvement.

Manufacturer Narrative

The bridge was returned to livanova (b)(4) for further investigation.Inspection of the returned device revealed that one of the pump units was very dirty and had bearing damage.A broken electronics motor was identified on the other pump.These damaged components were determined to be the cause of the reported issue.It is unknown how the components became damaged.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7167320
• MDR Text Key: 96627433
• Report Number: 9611109-2018-00016
• 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: 07/24/2018

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: 16-02-85
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1