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	01/24/2022
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).Through follow-up communication livanova learned that the cp5 display panel went blank during the case and the drive unit stopped.While hand cranking the drive unit the cp5 panel came back on by itself.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The control panel was replaced as precaution.Investigation is still ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) shut off during procedure.The customer performed hand-crank until the cp5 turned back on.There was no report of patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).Through follow-up communication livanova learned that the cp5 display panel went blank during the case and the drive unit stopped.While hand cranking the drive unit the cp5 panel came back on by itself.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The control panel was replaced as precaution.Investigation is still ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) shut off during procedure.The customer performed hand-crank until the cp5 turned back on.There was no report of patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H.10: the cp5 control panel involved in the issue was returned in livanova arvada and tested.The reported issue could not be reproduced: no error messages were displayed during the test and no loss of power occurred.The unit worked within specifications.The unit removed from service.No repair will be performed for this unit since a warranty unit was installed at the customer site.Based on the investigation performed for similar cases, the most likely root causes of the reported event are: an intermittent failure of the processor board on the cp5 control panel, which leads to lost can communication / power supply; an intermittent failure of the cable connecting the cp5 control panel to the s5 ep/pack.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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: 13577818
• Report Number: 9611109-2022-00074
• Device Sequence Number: 5731034
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)210308
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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