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

Model Number	48-40-00Z
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 pump gave a 'motor monitoring /control failed' error message during procedure.Pump was working and the customer could clear the error message, but it returned every 15 minutes.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 pump.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
A livanova field service engineer was dispatched to the customer site and was able to duplicate issue.To solve the issue, pump head and hkr board were replaced and all system flashed to be compatible.The device was tested 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.
Additional Manufacturer Narrative
H11: the involved computer board (hkr) was not retained for a deeper investigation for the following reason: no short-term or long-term trends have been detected for the reported type of failure; reportedly, no patient impact occurred; similar previous instances of the failure were reported and already investigated, finding the possible causes that, depending on the specific occurrence, caused the issue.Complaints database analysis revealed no similar event since unit installation in 2023.Based on the collected information, the root cause of the reported event can be trace back to a defective computer board (hkr).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.
Event or Problem Description
See initial report.

• Brand Name: S5 SYSTEM PRO VERSION
• 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: 18986325
• Report Number: 9611109-2024-00153
• Device Sequence Number: 19550253
• Product Code: DTQ
• UDI-Device Identifier: 04033817902676
• UDI-Public: (01)04033817902676(11)230321
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2024

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: 48-40-00Z
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 03/27/2024; 05/31/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/24/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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