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

Model Number	28-95-80
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova (b)(4) received a report that a s5 mast roller pump stopped several times during procedure.There was no report of patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 mast 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.
Additional Manufacturer Narrative
H10: through follow up communication livanova learned that an error message was displayed on the pump when the event occurred.The exact error message was not specified.A livanova field service representative tested the pump right after the event and could not reproduce the reported issue.An automatic reset/restart of the pump due to external interference is suspected.It seems that the automatic restart of the pump module occurred also with other two control panels.An odu disconnection was confirmed when using one of these two control panels which was not the same control panel used at the time of event.Investigation is in progress to clarify the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H.10: troubleshooting confirmed the failure of the contact on the odu connector between the pump and the e/p pack.The connector has been reseated and the problem could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
As reported in previous supplemental reports, through follow up communication livanova learned that an error message was displayed on the pump when the event occurred.The exact error message was not specified.In addition, through further follow up communication, livanova received confirmation of the serial number of the involved device (50e62395) which has been added to dedicated section d.4 and manufacturing date has been updated accordingly to h.4 section.As anticipated in previous supplemental reports, other control panels and associated pumps were involved.In detail, control panels (model number 28-95-85) 50e66084 and 50e66085 (manufactured on may 21, 2019) rebooted at the same time when the error message was displayed on 50e62395.The serial numbers of the pump modules (model number 10-88-60) associated to the control panels are 50e52414, 50e52415, 50e52416, 50e52417 manufactured on may 24, 2019.Further clarification regarding devices involved in the reported event is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Based on provided information the following could be determined: - suction pump sn (b)(6) connected to control panel sn (b)(6) stopped multiple times during procedure.The error message displayed was not remembered by the customer.In order to troubleshoot, user reset other pumps used on the same console (sn (b)(6) ), associated control panels are the following (b)(6).The involved pump was checked and tested by an authorized livanova field service technician.Upon checking the device, an improper connection of the pump sn (b)(6) odu connector from its a side part to control panel sn (b)(6) was identified.No further deviations were observed during the checks.Reportedly, all pumps are in use and perfectly functional at the customer site.Considering all the above facts, the most likely root cause of the reported event is related to improper connection of the odu connector to the pump control panel.
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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13313103
• Report Number: 9611109-2022-00032
• Device Sequence Number: 1580008
• Product Code: DWB
• UDI-Device Identifier: 04033817900818
• UDI-Public: (01)04033817900818(11)190523
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/21/2022

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: 28-95-80
• 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: 12/25/2021
• Supplement Date Received by Manufacturer: 04/06/2022; 05/11/2022; 06/22/2022; 10/22/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 05/07/2022; 06/08/2022; 07/21/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2019
• 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