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

Model Number	48-40-00
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report regarding console with alarm arterial clamp is defective and alarm arterial clamp does not open/close.No report of patient impact.
Additional Manufacturer Narrative
A.1.-a.5.There was no known patient involvement.H11: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
D.4 item code, sn, livanova has been updated.H.4 manufacturing date has been updated.H.11.The clamp was removed from service and returned to livanova for repair.The system was tested, and no deviations were identified.Subsequently, the clamp underwent a technical safety inspection (tsi) and was returned to the customer in full working order.A review of the device's service history found no prior reports of similar events.A similar occurrences have been reported to livanova.Based on the gathered elements and given that no issues were detected during testing, the root cause of the issue cannot be determined.Nevertheless, considering the results of past investigations into similar events, a temporary electrical issue, such as a loose connection or false contact, cannot be ruled out as a contributing factor to the complaint.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: SORIN S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 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: 20106353
• Report Number: 9611109-2024-00390
• Device Sequence Number: 8571797
• Product Code: DTQ
• UDI-Device Identifier: 04033817901068
• UDI-Public: (01)04033817901068(11)190916
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 48-40-00
• Device Catalogue Number: 60-05-65
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown