FDA Adverse Event Malfunction Summary report: N

ELECTRONIC GAS BLENDER

MDR report key: 23595151 · Received November 19, 2025

Report

Report Number: 9611109-2025-90533
Event Type: Malfunction
Date Received: November 19, 2025
Date of Event: October 20, 2025
Report Date: November 19, 2025
Manufacturer: LIVANOVA DEUTSCHLAND
Product Code: DTX
PMA / PMN Number: N.A.
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. G.5. THE S3 GASBLENDER 10 LITER (ITEM 25-40-00) IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO S5 GASBLENDER 10 LITER (ITEM CODE 25-40-45), WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K101046). H.4. MANUFACTURING DATE IS PENDING. H11: LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 0

LIVANOVA DEUTSCHLAND RECEIVED A REPORT REGARDING AN ELECTRONIC GAS BLENDER (EGB) THAT SHUT DOWN DURING EXTRA-CORPOREAL CIRCULATION, AFTER A MESSAGE CONCERNING COMMUNICATION ISSUE WITH THE HLM ESSENZ COCKPIT POPPED UP ON THE SCREEN. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IN PARALLEL, THE USER SWITCHED BACK ON THE AFFECTED EGB, THAT LOOKED TO PROPERLY WORKING UNTIL THE END OF SURGERY. AFTER THAT, IT SWITCHED OFF AGAIN BY ITSELF. THE UNIT HAS BEEN REPLACED BY A LOANER. THERE IS NO REPORT OF PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2316612	ELECTRONIC GAS BLENDER	GAS CONTROL UNIT, CARDIOPULMONARY BYPASS	DTX	LIVANOVA DEUTSCHLAND	MISCELATORE GAS S3 + ALLOGGIAM

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown