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

Model Number	10-88-60
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the s5 mast roller pump.The incident occurred in (b)(6) japan.Through follow-up communication it was learned that most likely potential equalization cable is not used by the customer.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 mast roller pump gave a motor controller error message (code 441) during procedure and it started working again when the message was cleared.There was no patient injury.
Additional Manufacturer Narrative
H11: according to additional information provided, no high frequency device was used during the procedure.Event log files of involved s5 mast roller pump provided by customer have been analysed.The analysis revealed that the pump stored software resets followed by the can timeout error (error 441 reported by customer).Can timeout error message indicates that the connection of the can bus to the pump has been temporary interrupted, and therefore the pump could not be controlled by the s5 system.The software reset of s5 devices is a designed protective function of the system: if the system detects an exception on the can bus signal, it performs a reset to prevent the exception to propagate and affect subsystems functionality.If the reboot is delayed, the timeout can be detected by the system.Possible causes for a delayed reboot are: persistent interference on the can bus; worn electronics related to multiple and not deterministic factors over time such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges.The signal on the can bus can be distorted by electromagnetic disturbances, for example if the system is not properly grounded with the mandatory potential equalization cable, but also in case of microprocessor failure on electronic boards.A livanova field service technician activity was conducted to test involved roller pump.The device was used and checked for a time period from 2 to 3 weeks, and no abnormality nor deviation was found also upon internal inspection.Based on the overall analysis, root cause of the reported event is most likely due to high frequences interferences in the operating room.If a reset occurs, the pumps restart themselves after few seconds, therefore the event is not likely to result in serious injury.Thus, the reported event was re-assessed as not reportable.
Event or Problem Description
See initial report.

• Brand Name: S5 MAST ROLLER PUMP
• 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: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19699276
• Report Number: 9611109-2024-00297
• Device Sequence Number: 14377903
• Product Code: DWB
• UDI-Device Identifier: 04033817900481
• UDI-Public: (01)04033817900481(11)181011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062396
• 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): 08/07/2024

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: 10-88-60
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2018
• 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