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	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a centrifugal pump 5 (cp5) gave motor controller centrifugal pump 1 failure message at setup.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in matsudo city, japan.Livanova initiated an investigation.This report was due on december 02, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on (b)(6) 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.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
H10: the unit was manufactured in 2015 and according to the analysis of the complaints database no similar events have been reported in the past.No service activity has been scheduled yet for this device.However, based on livanova knowledge the most likely error code associated to motor control failure on cp5 drive unit is the error code 458.The error code (458) can be due to a failure in the internal can communication between the computer board hkr (located in the cp5 control panel) and the motor control board hms (located in the drive unit).Based on the current level of information, the most likely root causes of the reported malfunction could be the following: - defective computer board (hkr); - defective motor control board (hms); - an incorrect connection between the cp5 drive unit and the cp5 control panel, which has led to a disconnection of the drive unit cable from the panel, resulting in a motor control failure.If service activity will be performed on this device or any additional information is received, a follow up on final report will be submitted.

• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18417466
• Report Number: 9611109-2023-00670
• Device Sequence Number: 15490203
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)151130
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/28/2024

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: 60-02-60
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2015
• 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