MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 SINGLE ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-80-00Z
Medical Device Problem Codes	Pumping Stopped (1503); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova deutschland manufactures the s5 roller pump.The incident occurred in kazakistan.The error appeared during pre-setup of the system; one day prior procedure.The following deay, the pump operated as it should.However, after some time, the error appeared again.A new roller pump150 is being delivered for replacement.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 preparation of the system for procedure, the s5 console displayed fault in motor controller error (error 432) at vent pump.There is no report of any patient injury.
Additional Manufacturer Narrative
A livanova service technician replaced the hms board to fix the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause is related to the delayed start of the dc/dc converter ic10.The complaint malfunction can only occur during the start-up phase (booting phase, t1 test).Once the dc/dc converter has started and the t1 test was positive, the pump is working as intended.The investigation showed that only converters with specific date code are concerned.The issue is always detected prior device through the functional tests to be performed at installation.Therefore, event has been reassessed as not reportable.A review of the complaint database was performed and it was highlighted that other similar events have been registered in the last months involving the roller pump installed on s5 pro.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: S5 SINGLE ROLLER PUMP 150
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16384949
• Report Number: 9611109-2023-00069
• Device Sequence Number: 20257395
• Product Code: DWB
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)221014
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• 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): 03/21/2023

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: 10-80-00Z
• Was Device Available for Evaluation?: Yes
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2022
• 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