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	Loss of Power (1475)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).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 a centrifugal pump console lost power during procedure.There was no report of patient injury.
Additional Manufacturer Narrative
A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported.Subsequent functional verification testing was completed without issues and the unit was returned to service.

• 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: 7333856
• Report Number: 9611109-2018-00211
• Device Sequence Number: 212895
• Product Code: KFM
• UDI-Device Identifier: 04033817901020
• UDI-Public: 010403381790102011160727
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 03/13/2018
• 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