MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 60-03-75

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative traced the problem to the cpu board.The cpu board was replaced to resolve the reported issue.A complete functional verification did not identify any 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.Evaluated on site by livanova technician.

Event Description

Livanova (b)(4) received a report that the centrifugal pump console displayed "no com" error on the pressure side and on the level/bubble side when it was powered on during a demo.There was no patient involvement.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6411876
• MDR Text Key: 70185966
• Report Number: 9611109-2017-00197
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-03-75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1