MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CP5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	PUMP CONTROL PANEL
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the cp5.The incident occurred in williamsport, pennsylvania.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The cp5 cord was moved from port #12 to port #10 on the side of the electronics and power (e/p) pack to be sure of a good connection.Lastly, serial readout (real time device parameters and setting recording file) was extracted to be analyzed.The unit was run for several hours without any deviation and therefore it was returned to service.Subsequent functional verification testing was completed without further issues and the unit was returned to service.In addition, through follow-up communication with the customer, it cannot be ruled out that the cp5 was switched off accidentally by the perfusionist during the surgery.He panicked when he saw the cp5 panel blank and he was running his hands along the back sides of the cp5 panel and was not sure if he bumped the switch back on or if it came back on by itself.Serial read out of the cp5 pump was analyzed and no relevant information related to the reported event was found.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 the screen of a cp5 shut off during procedure.There was no patient injury.
Additional Manufacturer Narrative
H11: the unit was installed in 2015 and reviewing the complaints in the database no further events were recorded before and after the event of september 2024.Therefore, the case is isolated.Based on evidence collected, a hardware malfunction of the device can be excluded and instead the shutdown of the control panel can most likely be associated with an unintentional user error.

• Brand Name: 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: 20512542
• Report Number: 9611109-2024-00486
• Device Sequence Number: 17919918
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)150821
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/16/2024

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: PUMP CONTROL PANEL
• Device Catalogue 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: 09/24/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2015
• 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