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

Model Number	10-88-60
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received report of a motor control failure error message on a s5 mast roller pump when used for the first time during maintenance.The pump was replaced with another.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 mast roller pump.The incident occurred in tanabe, japan.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: a livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Subsequent functional verification testing was completed without issues and the unit was returned to service, without repair activity, according to the customer.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2016.Based on the above and considering that no hardware failure was detected during technical and functional inspection, most likely root cause of the reported issue could be a user error during occlusion setup or in the tube used or the presence of a foreign object that blocked the rotor.
Event or Problem Description
See initial report.

• Brand Name: S5 MAST ROLLER 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: 15884639
• Report Number: 9611109-2022-00615
• Device Sequence Number: 20108632
• Product Code: DWB
• UDI-Device Identifier: 04033817900481
• UDI-Public: (01)04033817900481(11)160802
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062396
• 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): 11/30/2022

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: 10-88-60
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2016
• 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