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

Model Number	60-03-75
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump console.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 was unable to correct the problem by rebooting the device.The service representative re-seated all connections on the back plane, cpu and interface boards, but the issue persisted.The cpu board was replaced and the issue was resolved.Subsequent testing found the device to be functioning according to specifications.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.Device not returned.
Event or Problem Description
Livanova (b)(4) received a report that the display of the centrifugal pump console became blank and the background turned blue during setup.The device was restarted and began to function as expected.There was no patient involvement.
Additional Manufacturer Narrative
The defective board was returned to livanova (b)(4) for further investigation.During the investigation the reported failure could be confirmed and traced back to a defective memory on the board.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7135926
• Report Number: 9611109-2017-01034
• Device Sequence Number: 1068919
• Product Code: KFM
• UDI-Device Identifier: 04033817901020
• UDI-Public: 010403381790102011170614
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K020571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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
• Operator of Device: Health Professional
• Device Model Number: 60-03-75
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1