MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 CONSOLE FOR 4 PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 48-40-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 05/26/2021

Event Type  Injury  

Event Description

Livanova has been informed of a legal claims against the perfusionist of the case in which the problem occurred have been issued.Livanova is not a party in the lawsuit, but it is requested to provided documents.It looks like the plaintiff had bypass surgery on (b)(6) 2021 and when he was weaned off bypass, an adverse event occurred causing the arterial line to fill with air.Plaintiff allegedly suffered a ¿massive air embolism post revascularization and went into cardiogenic shock.".

Manufacturer Narrative

A.1.- a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 system.The incident occurred in united states.Livanova initially received the information of air in line during procedure without any patient impact.The case was assessed not reportable.A livanova fse was dispatched to the customer's facility, tested the s5 system and identified no deviations.Nvmem clear was then performed on each of the four pumps.Functional verification checks were performed and passed positively.The unit was put back in service.A livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 CONSOLE FOR 4 PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 18949702
• MDR Text Key: 338244341
• Report Number: 9611109-2024-00142
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1