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	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, during a procedure, three (3) different roller pumps used as sucker displayed motor control error (e441).There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 console.Pictures and read-out of the involved sucker pumps was provided and it was possible to confirm that all 3 pumps were affected.Livanova fse confirmed that the s5 console worked properly during service activity at the customer site, s5 has been turned on correctly and all pumps were functioning without any alarms or error codes.During the service activity, internal connections were checked and no problem was found.Moreover, the s5 console and pumps worked correctly all day long, no alarms or malfunctions were displayed.The equipotential cable was connected regularly.Serial read out (real time device parameters and setting recording file) of the 3 pumps were collected and analyzed: can_timeout error is stored, which corresponds to the code 441: motor controller failed.Then the pumps switched off due to an error (motor_not_connected) and a reset of modules during watchdog is stored.The watchdog reset of s5 devices is a designed protective function of the system: if the system detects an exception (i.E.An unexpected bit sequence) on the can bus signal, it performs a reset to prevent the exception to propagate and affect subsystems functionality.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: the signal on the can bus can be distorted by electromagnetic disturbances, but also in case of microprocessor failure on electronic boards.Considering that several simultaneous exception were stored on different pumps and that no deviation has been found during technical inspection of the console, it is possible to exclude any electronic boards deviation, while the most likely cause of the event can be related to an external interference from high frequency unknown device.Based on the analysis performed, we can reasonably exclude any malfunction of the s5 console.

• 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: 20480318
• Report Number: 9611109-2024-00484
• Device Sequence Number: 8091382
• Product Code: DTQ
• UDI-Device Identifier: 04033817900894
• UDI-Public: (01)04033817900894(11)190701
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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?: 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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