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	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in tomisato, japan.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.During inspection of the unit, it was found the presence of a fluid / oil from inside the cp5 drive unit.In order to solve the issue, printed circuit board (pcb) was replaced.Subsequent functional verification testing was completed without further issues.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) gave a motor controller and a runaway (the pump ran too fast - set value different to actual value) error messages during setup and the device could no longer be used.Due to a power problem, the operation was completed after the device was replaced with another pump.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The pcb board that belonged to the claimed cp5 was fitted into a functioning demo cp5 and it was observed that the device stopped working after the replacement.The cp5 readout was pulled and sent for further investigation.The analysis of the log has pointed out that the claimed issue occurred four times.In addition, other messages related to communication with the can interrupted or blocked were recorded.The faulty cp5 was returned to livanova for repair.The problem was confirmed and the scp magnetic disk, washer, shim, bearing scp and motor controller cp5 were replaced to solve the issue.Functional verification checks were performed and passed positively.The unit returned to service.A device service history review has been performed and identified that the unit was manufactured in 2022 and no other similar events have been reported.No trend has been captured for the mentioned type of issue.Based on the collected information, the cause of the event has been traced back to a defective motor control (#90-305-990).The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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: 19906206
• Report Number: 9611109-2024-00350
• Device Sequence Number: 7080243
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)220226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 07/09/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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