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	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, age or date of birth, sex, weight, ethnicity; there was no patient involvement.Livanova deutschland manufactures the s5 double head pump.The incident occurred in ankara, turkey.A field service technician was dispatched to the facility to investigate the device and could confirm the reported issue.The fault was traced back to motor power amplifier board which need to be replaced.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 a s5 double head pump gave a motor control failure error message during a procedure.There was no patient injury.
Additional Manufacturer Narrative
Motor power amplifier board was replaced in order to solve the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.It cannot be ruled out that an early deviation of an electronic component of the replaced board led to the involved pump to malfunction.
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: 15679559
• Report Number: 9611109-2022-00551
• Device Sequence Number: 6462320
• Product Code: DWB
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)200908
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 01/19/2023

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: 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: 09/30/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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