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

Model Number	10-88-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in marseille, (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 (b)(4) received a report that a s5 mast roller pump stopped during a procedure.The user hand-cranked the pump and after several attempts the pump could be started again.There was no report of patient injury.
Additional Manufacturer Narrative
The involved roller pump and its control panel was manufactured in 2020 and according to the review of the complaint database, no further events related to this unit have been reported in the past.The possible cause of the reported issue can be: - hardware malfunctions with internal components (hms board, hms board, pump resolver); - user error (such as incorrect occlusion or set tubing size).The device was returned to manufacturer for a dedicated investigation.The device was tested simulating the use condition.No deviations were observed during the entire test, the pump never stopped and no alarms / error messages have been displayed on the s5 control display module.In addition, serial readout analysis performed on the other pumps of the console did not revealed any harware malfunction and excluded any external electromagnetic interference.No hardware malfunction identified potential user error cannot be ruled out as most likely root cause of the event, such as incorrect occlusion or set tubing size.No specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.

• 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
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13468734
• Report Number: 9611109-2022-00053
• Device Sequence Number: 3963967
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)201110
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 10-88-00
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2020
• 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