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

Catalog Number	48-50-00
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	04/19/2024
Type of Reportable Event	Death
Event or Problem Description
Livanova deutschland received a report from aemps of a death case in which a s5 system was used.Customer has not notified directly livanova of the event when it occurred, as he did not consider the s5 device to be involved.
Additional Manufacturer Narrative
Through follow-up communication with the customer, livanova learned that the patient was a young boy and during the intervention there was a massive entry of air that caused the death of the patient.S5 worked properly and no alarms went off.Customer is in contact with the commercial company that provided him with the normothermia modules as well as the corresponding consumables.From the review of the database, no further event was reported on this console, that was manufactured in 2016.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Technical service interventions and preventive maintenance activities were verified and confirmed to have been carried out on time and with no issue.Based on all information collected, no adverse event related to livanova machine was confirmed nor any correlation to patient's death was complained by customer.Therefore, there is no relationship between the reported adverse event and livanova device.No other action is deemed necessary.The risk is in the acceptable region.Livanova maintains and documents periodic customer events monitoring process to evaluate actions for products improvement.Livanova will keep monitoring the market.

• Brand Name: S5 HEART-LUNG-MACHINE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 20065346
• Report Number: 9611109-2024-00384
• Device Sequence Number: 12708952
• Product Code: DTQ
• UDI-Device Identifier: 04033817900900
• UDI-Public: (01)04033817900900(11)161128
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial
• Report Date (Section B): 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 48-50-00
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/26/2024
• Date Device Manufactured: 11/28/2016
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown