MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 CONSOLE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	48-40-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 console centrifugal pump stopped due to run away error during a procedure.The medical team was able to finish case.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the s5 console.A livanova field service representative was dispatched to the facility to investigate the device and the fse downloaded the report of the pump control panel the fse suggested replacing the drive motor and shaft angle encoder the problem coming back.At this time customer did not want parts replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: livanova field service representative in charge returned at customer's facility and in order to solve the issue the cp5 drive motor was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The serial read-out of the pump (real time device parameters and setting recording file) was analyzed.Since the date of the event is september 5th, in this date the following error was stored in the log files: 05.09.24*11:47:53.415 18=obsrv 1c1h=runaway peak 000ah which confirms what the customer reported, therefore a pump speed different from the set value.A device service history review has been performed and identified that the unit was manufactured in 2023 and no other similar event has been reported, neither concerning trend has been identified.Pump speed faster than expected could be due to hand crank not turning off the pump itself.However, based on the evidence that had to lead to the replacement of the entire cp5 drive unit, it cannot be ruled out that the most likely root cause is related to a defect in the board that controls the motor.
Event or Problem Description
See initial report.

• Brand Name: S5 CONSOLE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 20366102
• Report Number: 9611109-2024-00453
• Device Sequence Number: 6878590
• Product Code: DTQ
• UDI-Device Identifier: 04033817900894
• UDI-Public: (01)04033817900894(11)190613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 48-40-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2019
• 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