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

Model Number	60-02-60Z
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that it could not get forward flow and pressure on centrifugal pump 5 (cp5) through oxygenator.The issue occurred while attempting to go on bypass.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 (b)(6).Through follow-up communication livanova learned that initially, while attempting to go on bypass, flow was 3.5 lpm and pressure value was acceptable.Then, perfusionist leaned over to turn on gas and timers and when he looked back at cp5, flow was at 0.00 lpm and low and negative alarm sounded.All attempts to re-establish flow were unsuccessful, therefore s5 was swapped out with backup pump and case finished with no other issues.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.As a precaution the flow control board (pcb) and the flow probe were replaced.This report was due on november 28, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 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 serial read-out of the centrifugal pump (real-time device parameters and setting recording file) was gathered and analyzed.On the date of event only a rc_index_impulse_missing is present and signals that impulse is missing from actual rotational speed, that is the speed signal from the hall sensor is not transferred to the main circuit board (cpu).This can be due to a defective hall sensor, defective motor control board (hms) on the connection for hall sensor or disconnection of the drive unit from the control panel.Since it was reported that the centrifugal pump was replaced with another one, it is likely that the error stored is due to the disconnection of the pump to replace it.Involved disposables were also requested for investigation.Visual inspection of the returned oxygenator and revolution pump revealed no visible defects.Laboratory test could not reproduce any increased pressure drop across the oxygenator that could have prevented normal flow during case.Unit behaved as expected without any performance deviation identified in terms of pressure excursion in blood path.Returned device did not exhibit any increased hydraulic resistance during the test: fibers were found patent and not occluded.No manufacturing quality issue possibly linked with the reported condition was confirmed accordingly.No issue was detected with the revolution pump as well, that worked as expected.Based on investigation findings, no issue with the disposable could be confirmed.A device service history review has been performed and identified that the unit was manufactured in 2022 and another similar event has been reported in 2023.In that case the reported restriction of blood flow was most likely associated with machine settings in terms of alarm and warning limits for pressure that regulated the flow.Based on all the gathered information, it cannot be excluded that a temporary malfunction of the flow probe or module caused a continuous reoccurrence of negative flow alarms that close the electrical remote-controlled (erc) mounted on the system and prevented the flow to be re-established.

• 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: 18356288
• Report Number: 9611109-2023-00645
• Device Sequence Number: 15184357
• Product Code: DWA
• UDI-Device Identifier: 04033817902782
• UDI-Public: (01)04033817902782(11)221124
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/18/2024

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: 60-02-60Z
• 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: 10/29/2023
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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