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

Model Number	10-85-00Z
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no known patient involvement.G.5.The s5 double head pump 10-85-00z is not distributed in the usa and it is similar to s5 double head pump 10-85-00, which is distributed in the usa (510(k) number: k071318).Through follow-up communication livanova learnt that the alarm occurred during first procedure after installation.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 a report about console alarms with "fault in motor controller (431) pump 2a (blood) , fault in motor controller (433) pump 2a (blood) and fault in motor controller (442) pump 2a (blood)" when turned on.The field service engineer has done the swapping process with other spare parts to determine which spare parts are damaged.It was concluded that the damage was on the power amplifier motor board and the roller pump 85 pump head rotor in pump 2a.
Additional Manufacturer Narrative
The distributor engineer on site inspected the unit and tested it swapping components to spare parts to determine which was damaged and found that power amplifier motor hmf 0408 and the rp 85 pump head of pump 2a were faulty.Pump was returned to munich for repair.Upon inspection error could be confirmed: message "fault in motor controller 431 pump 2a" was displayed at the power on of the pump, resulting in no control on pump 2a (whereas pump 2b was working properly).After swapping the connector pump a and b on the hkr board, the same failure message 431 of pump 2a was displayed.In addition, the message "motor monitoring/control failed pump 2b" was displayed with pump 2b stopping to work after few second from the power on.As troubleshooting the hmf 0408 motor amplifier board, the hms 0409 motor controller and the pump head were replaced.Connectors of pump a and b were reestablished in the original configuration and unit returned to service after functional test passed positively.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Based on all the above, the most likely root cause of the reported event has been assigned to an electrical failure of the motor amplifier board and the pump head of pump 2a.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.

• Brand Name: S5 DOUBLE HEAD PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 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: 20085551
• Report Number: 9611109-2024-00385
• Device Sequence Number: 18042191
• Product Code: DTQ
• UDI-Device Identifier: 04033817902737
• UDI-Public: (01)04033817902737(11)230901
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 10-85-00Z
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown