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

Model Number	10-85-00
Medical Device Problem Code	Decreased Pump Speed (1500)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received report that a s5 double roller pump failed during priming.While setting up the perfusionist checked the occlusion on the small roller pump and then turned the pump rpms to 0.After finishing up with preparing for the case he noticed that the screen showed dashes and no longer read 0.00 lpm and rpm.A picture was provided.The pump was restarted multiple times and plugged it into different ports on the base of the s5.However, the issue persisted and another roller pump was used for the case.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 double roller pump.The incident occurred in (b)(6).Through follow-up communication livanova learnt that the knob od the pump did not do anything when it was turned and it initially worked until it no longer showed flow or rpms.Service engineer replace the device at the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The unit returned to the manufacturing site confirming the reported issue.The internal inspection of the device showed that the connection between the computer board and the motor power amplifier board was loose, in particular the yellow cable was completely detached from the connector.Therefore, connection was restored.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Most likely root cause of the reported event was the signal discontinuity between the electronic components, that was caused by an isolated manufacturing deviation enhanced by device use conditions/transportation.
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; 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: 15388906
• Report Number: 9611109-2022-00457
• Device Sequence Number: 5648730
• Product Code: DWB
• UDI-Device Identifier: 04033817902737
• UDI-Public: (01)04033817902737(11)220622
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/02/2022

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: 10-85-00
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2022
• 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