MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-02-60
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduced the reported issue.However, pictures of two error codes were shared with livanova and the event could be confirmed.Thus, the processor board of the cp5 control panel was replaced as well as the cp5 drive unit.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received report that rpms and flow on would go to zero on a centrifugal pump 5 (cp5) during procedure.Reportedly, three alarms were displayed.The first one was associated to graphic display failure, the second to a short-term internal malfunction and the third to no monitoring/control function active for the pump.Thus, the system was switched out with another.There was no report of patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H.10: processor board and cp5 drive unit were returned for investigation to livanova arvada facility.The drive unit was functionally tested and found to be working as per specifications.Thus, the most likely root cause of the reported event was a defective electrical/electronic component of the processor board of the cp5 control panel.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 14049956
• Report Number: 9611109-2022-00164
• Device Sequence Number: 14960286
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)200303
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 60-02-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown