MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH MAST ROLLER PUMP 85; 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	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.The serial number and udi are pending.They will be provied in follow up report if available.The mfg date is pending.It will be provied in follow up report if available livanova deutschland manufactures the s5 mast roller pump.The incident occurred in japan.A new electronic and power pack and pump has been requested.Investigation is ongoing.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, before starting cardiopulmonary bypass, the mast roller pump 85 lost power, then recovered naturally, and then again the power went down.By replacing the tubing from the defective pump to another pump, medical team was able to start cardiopulmonary bypass without any problems and without any impact on the patient.
Additional Manufacturer Narrative
D.4.Sn of the involved pump was provided and it has been inserted in present report together with udi.H.4.Sn of the involved pump was provided and it has been inserted in present report together with manufacturing date.H.11.A field service representative was dispatched to the facility to investigate the device.The pump was inspected internally and in operation on-site, and no abnormalities were found, so it was determined to be normal and only the e/p pack was replaced (as well as ups and dcdc module) with a replacement unit.No other component have been replaced yet.E/p pack was inspected it at the livanova warehouse and no fault confirmed.The electrostatic discharge test was performed 10 times at 1 second intervals, with a contact discharge of +6000v and an air discharge of +8000v.The e/p pack connectors and the pump control panel knobs were tested to determine where static electricity may be generated and where it may be affected by signals on the can and could have caused the reported issue.As a result, the pumps were working normally, therefore it was excluded as root cause.Serial read out (real time device parameters and setting recording file) of the pumps were not collected.It remains unknown: time required to the pumps to restart.If any potential equalization cable was in use at customer site.If customer restarted flow from the knobs remains unknown.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
Despite several requests, no information regarding potential equalization cable and duration of reboots was provided.A device service history review has been performed and identified that the pumps were manufactured in 2019 and no other similar event has been reported, neither concerning trend has been identified.Based on all the gathered information, the most likely root cause of the reported event may be related to temporary electrical failure of the pumps due to false contact/bad connection to the ep pack, resolved during technician inspection or/and external interference from high frequency devices.It is strongly recommended to check the operating theater and the ambient of the operating theater for emissions of high frequency emitting devices and to always have connected the potential equalization cable to earth (see ifu, chapter 2.2.6, cp_ifu_5811-0000).Our equipment meets all the requirements of the standard iec 60601-1-2:2014 for the electromagnetic disturbances.Therefore, we can exclude that our devices are responsible for the issues occurring in the field.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: MAST ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 19423623
• Report Number: 9611109-2024-00236
• Device Sequence Number: 18226560
• Product Code: DTQ
• UDI-Device Identifier: 04033817900481
• UDI-Public: (01)04033817900481(11)190813
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103762
• 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): 01/27/2025

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 10/11/2024; 12/29/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 11/08/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2019
• 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