MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND MAST ROLLER PUMP 150; 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	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 mast roller pump stopped in operation giving an error message related to motor control.The pump started again immediately.The issue occurred during maintenance activities.There was no patient involvement.
Additional Manufacturer Narrative
Livanova deutschland manufactures the s5 mast roller pump, the incident occurred in germany.Read out the pump send the manufacturer for verification.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
The pump involved was manufactured in 2020 and the review of the events on the serial number has highlighted no other complaints identified since its installation, therefore the case is isolated.No other additional information was provided on the event that occurred and no subsequent events were submitted by the customer on the impacted pump.There is no evidence of service intervention request confirmation by the customer.The presumed date of the event would be january 13, 2023, and the read-out analysis confirmed that no deviations/alarms/errors were stored on that date.Based on the findings mentioned above, an intrinsic failure of the electro-mechanical component can be excluded.Based on all facts above, the reported deviation only happened once and the root cause could be most likely related to a specific condition of custom pack setting inside the pump raceway / user technique or motor blocked by foreign object.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Additional Manufacturer Narrative
The claimed error was displayed during a procedure (not during a maintenance) and not patient impact was reported.The complained error remains unknown (not found in the log file) and could not be reproduced.The complained pump was extensively tested by the livanova field service engineer and no issue could be found.Livanova field service engineer advised the customer to use the potential equalization cable.Based on the above, an intrinsic failure of the electro-mechanical component can be excluded.The reported deviation is isolated (happened once) and the most probable root cause was high frequency interferences from other device and/or a specific use condition and/or motor blocked by foreign object.Since the issue was not ascribable to any device malfunction, the event is being reassessed as not reportable.
Event or Problem Description
See intial report.

• Brand Name: MAST ROLLER PUMP 150
• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16349693
• Report Number: 9611109-2023-00057
• Device Sequence Number: 6318658
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)200630
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2024

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 01/12/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 08/24/2023; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2020
• 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