MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 DOUBLE ROLLER PUMP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-85-00Z
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the s5 double roller pump 85.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 s5 double roller pump displayed fault in motor controller (e432) during a procedure.There was no report of any patient injury.
Additional Manufacturer Narrative
H 11: the complained pump was investigated.Initial test run confirmed the reported issue: error code 432 occurred a few minutes after startup on the s5 double roller pump 85 side b.To solve the issue, both motor control boards (motor end stage board s5 and motor control hms0409) have been replaced.Unit tested without further issue and returned to customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Serial read out (real time device parameters and setting recording file) of the pump was collected and do not report error messages on the alleged event date (october 16th, 2024).However multiple error codes 432 (rc_resolver) were recorded on september 19th, 25th and 26th, 2024, confirming the issue with the pump.The review of machine service history revealed that it was installed in 2024 and the dhr did not reveal any non-conformity nor deviation during manufacturing.Based on the above, the most likely root cause of the issue is related to an early failure of the motor control boards.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impact (drops and falls), and power overloads/surges but also to variability of micro subcomponents.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• 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 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20672345
• Report Number: 9611109-2024-00542
• Device Sequence Number: 7285288
• Product Code: DTQ
• UDI-Device Identifier: 04033817902737
• UDI-Public: (01)04033817902737(11)240731
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 04/28/2025

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: 10-85-00Z
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 03/31/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/12/2024; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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