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

Model Number	48-30-00
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that during procedure a s5 roller pump did not stop after the liquid passed through the bubble sensor; the user did not see any visual or audible alarm.The circuit used by the customer includes an air purge control (apc) filter utilized with a servo drive on a s5 roller pump and a 3/8" bubble sensor.The s5 system was linked to a centrifugal pump system (scp).There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided h10: livanova deutschland manufactures the s5 system.The incident occurred in france.A livanova "initiated" an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
A complaints database review was performed and no other issue has been reported for the claimed unit since its installation in 2017.Moreover, no other similar occurrence has been submitted by the customer in the past and following apc module replacement.Based on available information, it cannot be ruled out that the reported issue can be traced back to a defective apc module.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Through follow-up livanova discover that the problem came back only once and there is doubt about bubble sensor installation.The field service eng.Set-up an apc loan module and requested additional investigation from apc expert.If additional relevant information will be provided a follow-up report will be submitted.

• Brand Name: S5 HEART-LUNG-MACHINE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 16681778
• Report Number: 9611109-2023-00147
• Device Sequence Number: 7950139
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: 010403381790088711170530
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 11/14/2023

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: 48-30-00
• Was Device Available for Evaluation?: Yes
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 10/25/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 09/25/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2017
• 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