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

Model Number	10-80-00Z
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in (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 deutschland received a report that a s5 roller pump did not run smoothly.The issue occurred during priming.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
A livanova field service representative was dispatched to the facility to investigate the device and two (2) pump heads to the pumps rp150 10-80-00z (sn (b)(6)) and to the pump mrp150 10-88-00 (sn (b)(6)) were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: complaints database analysis revealed that no similar event occurred since unit installation in 2022.Based on the collected information and considering that the issue has been solved by replacing the pump head, it cannot be ruled out that the root cause of the event is a faulty motor controller board located in the pump head.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impact (drops and falls), and power overloads/surges but also to variability of micro sub-components.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Udi related data quality updates only d2a.Common device name has been corrected in the dedicated section.D2b.Device product code has been corrected in the dedicated section.G.4 pma/510(k) number has been corrected in the dedicated section.

• Brand Name: S5 ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18381746
• Report Number: 9611109-2023-00653
• Device Sequence Number: 15254272
• Product Code: DTQ
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)221223
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K210130
• 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,Followup,Followup
• Report Date (Section B): 08/16/2024
• 2 Devices were Involved in the Event: 1 2

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: 10-80-00Z
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 05/14/2024; 06/13/2024; 08/08/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 06/11/2024; 07/08/2024; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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