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

Model Number	48-40-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the sorin s5 system.The incident occurred in usa.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that the s5 console for 4 pump was not working properly during set up.There was no patient involvement.
Additional Manufacturer Narrative
A livanova field service visited the customer for the preventive maintenance of the heart lung machine and no issue was found.Customer wanted to know if there was a cleaning procedure for the s5 confusing it with the 3t heater coolers.Based on the information received, no device alleged malfunction occurred.Therefore, event has been reassessed as not reportable.No other action is deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.

• Brand Name: S5 CONSOLE FOR 4 PUMP
• Common Device Name: 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: 19246684
• Report Number: 9611109-2024-00203
• Device Sequence Number: 20644009
• Product Code: DTQ
• UDI-Device Identifier: 04033817900894
• UDI-Public: 010403381790089411161109
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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 Model Number: 48-40-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2016
• 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