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

Model Number 48-30-00

Device Problems No Audible Alarm (1019); No Audible Prompt/Feedback (2282)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the sorin s5 system.The incident occurred in germany.A livanova field service representative was dispatched to the facility to investigate the device.According to customer information, the issue is a sporadic error, no acoustic alarms (entire hlm), alarm only occurs visually.The alarm displayed was not reported and it is unknown.The console was tested, checked of all alarms (return after muting, high and low priority), plug connectors checked, recording carried out using pcan explorer, no error messages found on the can bus.The fault complained about could be resolved within 3 hours.Test run cannot be reproduced.Test run ok and no spare part was requested.Unit returned to customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that, during priming, the s5 console displayed visual alarm and no acoustic alarm.Medical team switched the machine off and on and it worked for a while; then no acoustic alarm was heard again.There was no patient involvement.

• Brand Name: SORIN S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• 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: 18500787
• MDR Text Key: 332734687
• Report Number: 9611109-2024-00027
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: (01)04033817900887(11)171120
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-30-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1