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

Model Number	48-40-00Z
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(6) manufactures the s5 system.The incident occurred in (b)(6).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 received report that when switching on the s5 system after few minutes, a pump gave an error message associated to a shaft encoder fault.Reportedly, the error message was coming continuously and pump was not running.The connections were checked and reinsert but the problem persisted.There was no patient involvement.
Additional Manufacturer Narrative
H.10: the serial number of the affected roller pump used on the s5 system was provided: model number: 10-80-00.Serial number: (b)(6).Udi code: (b)(4).Manufacturing date of device: february 11, 2022.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The processor board and the shaft angle encoder were replaced and the problem was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Based on analysis of manufacturing records, a deviation during manufacturing process could be ruled out.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
Livanova received a report that when turning on the s5 system after a few minutes, a roller pump gave an error message 'shaft encoder fault pump 2' associated with an encoder failure.The error message kept coming up and the pump didn't work.The connections have been checked and re-entered and the problem persisted.There was no patient involvement.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The computer board hkr and the shaft angle encoder were replaced and the problem was fixed.The device had been used in two procedures following the replacement of the components, with no other errors.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The involved computer board hkr 0325 shaft angle encoder were returned to the manufacturing site and visual inspection of all components found no defects/burnt/damage.No ncr related to the pumps serial number or one of the replaced components was issued.Based on the analysis of dhr, it can be ruled out a deviation occurred during manufacturing process.Review of similar cases on impacted code: 10-80-00z manufactured in 2022 was performed, highlighting that no complaints were identified in the database.Thus, the case is isolated.Based on the above, it cannot be ruled out that the root cause of the reported event could be traced back to an inherent failure of the electro-mechanical components.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 intial report.

• Brand Name: 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 14432973
• Report Number: 9611109-2022-00244
• Device Sequence Number: 5658585
• Product Code: DTQ
• UDI-Device Identifier: 04033817902676
• UDI-Public: (01)04033817902676(11)220215
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/21/2022

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 Model Number: 48-40-00Z
• 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: 04/18/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 11/21/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/08/2022; 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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