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

Catalog Number	48-50-00
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 pump started smoking during a case.Simultaneously, a ¿pop¿ was heard.The pump transitioned to battery.The perfusionist unplugged the pump and ran on battery for the remainder of the case.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova deutschland manufactures the s5 system.The incident occurred in rochester, minnesota, united states.The customer provided a picture showing a completely burned out connection module.Melted components are visible.A livanova intiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.The customer provided a photo showing s5 mains power.
Additional Manufacturer Narrative
H10: through follow-up communication livanova learned that battery power was established without loss in arterial pump blood flow.Electrical cord was disconnected from it's source and smoke/smell dispersed.Moreover, the customer will not be returning the unit for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2018.It cannot be ruled out that an over-current caused the short-circuit protection of the device, leading the device to run on battery.Since the event is isolated, most likely the root cause of the over-current is traced back to an excessive load due to an electronic component deviation of s5 mains power connection module.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to fix the issue, electronics and power (e/p) pack was replaced with a new one with new dc/dc (direct current) convertor; cabling was rerouted and 5th pump reinstalled.S5 system was upgraded to 3.16 software version and flashed with #1506 arrangement.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: SORIN S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15824075
• Report Number: 9611109-2022-00600
• Device Sequence Number: 14952011
• Product Code: DTQ
• UDI-Device Identifier: 04033817900900
• UDI-Public: 010403381790090011180725
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48-50-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 01/18/2023; 02/20/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/20/2022; 02/16/2023; 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2018
• 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
• Patient Sex: Unknown