S5 CONSOLE
Received Jul 17, 2026 · Event occurred Jun 2, 2026
Report 9611109-2026-90318 · MDR key 25854567
Device
Generic name
Console, Heart-lung Machine, Cardiopulmonary Bypass
Manufacturer
Livanova Deutschland GmbhModel number
SRD S5 CONSOLE FOR 4 PUMPCatalog number
48-40-00Z
Product problems
- Pumping Stopped
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING SURGERY, S5 HLM PUMPS RESTARTED AUTOMATICALLY 8 TIMES, BOTH SIMOULTANEOUSLY AND INDIVIDUALLY: PUMPS SHUT DOWN AND THE DISPLAYS WENT BLANK. BLUE SCREENS WITH A WHITE BAR THEN APPEARED, AFTER WHICH THE PUMPS SOFTWARE RELOADED.THE FOLLOWING TWO ERROR MESAGES APPEARED ON THE INVOLVED DOUBLE PUMP:"FAULT IN THE MOTOR CONTROLLER (E441) PUMP 4B" "SHORT-TERM INTERNAL ERROR, STILL OPERATIONAL PUMP 4A AND 4B". THERE IS NO REPORT OF ANY PATIENT INJURY.
Additional Manufacturer Narrative
A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED.H11:LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 HLM SYSTEM.THE EVENT OCCURRED IN POLAND.LOG FILE ANALYSIS WAS PERFORMED AND IDENTIFIED THAT CAN BUS SIGNAL DISTURBANCES OCCURRED ON TWO OF THE HLM ROLLER PUMPS.LIVANOVA HAS INITIATED AN INVESTIGATION.