MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH PUMP CONTROL PANEL (CP5); CONSOLE, HEART-LUNG MACHINE, 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	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: livanova deutschland manufactures the s5 system.The incident occurred in united states.Perfusionist reported the cp5 display went blank with a white vertical line.They hand cranked until they were able to get the cp5 display to turn back on, then they finished the case with the cp5.A livanova field service engineer was dispatched to the customer and was unable to duplicate the issue.When testing with the new display it was noticed the flow was fluctuating at 0.00.The flow module was replaced to resolve this.The s5 was updated to latest software version.The s5/cp5 was tested and returned to customer.The serial read out (real time device parameters and setting recording file) of the cp5 pump was collected and will be investigated.The replaced cp5 display will be sent for analysis.A livanova initiated an investigation.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 has received a report that during a procedure, cp5 pump shut down.The customer has hand cranked the pump while rebooting it.After rebooting the cp5 pump was working again and the procedure was completed with no issue.There is no report of any patient injury.
Additional Manufacturer Narrative
H10: a device service history review has been performed and identified that the cp5 control panel was manufactured in 2018 and no other similar event has been reported.The affected part was returned to livanova deutschland for a detailed investigation.Technical safety inspection and 12 hours run test were performed; a clear of the non volatile memory (nvmem) was not possible.The following parts were replaced: led display touchscreen computer board flashed to a new software version ribbon cable and flat ribbon cable gasket for lcd touchscreen.The read-out of the involved pump (real-time device parameters and setting recording file) was gathered and analyzed.Can bus connection stop was confirmed on the date of event.Based on the outcome of technical service activity and taking into account the parts replaced, it cannot be ruled out that a temporary failure of the cp5 display interrupted the can bus connection and the pump stopped for this reason.
Event or Problem Description
See initial report.

• Brand Name: PUMP CONTROL PANEL (CP5)
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munica
• 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: 17343045
• Report Number: 9611109-2023-00336
• Device Sequence Number: 17775672
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)180522
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210130
• 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): 07/18/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/19/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2018
• 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