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

Model Number	60-01-04
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.D.4.Serial number is unknown.This information will be provided in a supplemental report if made available.H.4.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in yokohama, japan.Unit vibration occurred when the involved cp5 drive unit started to operate, not with another cp5 drive unit.Due to the above symptoms, the machine was replaced by the customer with another one.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that a centrifugal pump 5 (cp5) control panel power went out during a procedure.The power automatically turned on again, and then there was no problem in using it after that.The issue occurred two (2) times in a surgery.There was no patient injury.
Additional Manufacturer Narrative
Through follow-up communication livanova learned the involved device serial number.Model/serial numbers have been added to the dedicated section.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.However, when the angle of the drive unit was changed, the symptom was reproduced.The affected part will be shipped to manufacturer's site for investigation and repair.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The cp5 control panel was inspected by a livanova field service engineer.The issue couldn't be reproduced and no device deviation was detected during electrical checks and functional tests.For precautionary reasons, the field service engineer elected to replace the parts that could be related to the reported issue.The cp5 control panel was manufactured in 2018 and no other issues have been reported to livanova since device installation.Based on the above facts and on the investigation performed for similar cases (cp5 control panel which shut off without displaying error messages), the most likely root cause of the reported event is traced back to: an intermittent failure of the cpu 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.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial 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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17141511
• Report Number: 9611109-2023-00269
• Device Sequence Number: 7662779
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)180823
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/22/2024

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: 60-01-04
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 07/31/2023; 12/29/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/28/2023; 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2018
• 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