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	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 mast roller pump stopped during the case and there was no alarm, either audible or visual.Customer tried to restart the pump without success, therefore hand crank was started; normal alarms of runaway motor due to hand cranking appeared.The pump was then turned off and on again and stopped hand cranking: the value on the screen went up, but the pump didn't turn.Customer believed to have the pump lid overridden at this point, however no alarm was working on the involved arterial pump.Lastly, the affected pump was changed with a centrifugal one and everything started again.Surgery was completed with no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 mast roller pump.The incident occurred in (b)(6).Through follow-up communication livanova learned that the involved arterial pump stopped during case on (b)(6) 2023 at around 17:05 or 17:06.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue: affected pump was working properly when turned on.Full functional testing was completed on the pump, also with the sensors connected, no issue arisen.Moreover, a completed a simulation of what occurred was performed and when hand cranking was done, the alarms still worked.Pump was then changed out for a loan and has been taken back to the workshop for review.Loan roller pump was installed and fully tested, also with sensors, without issues.In addition, e/p (electronics and power) pack was changed as per customer's request.The serial read-out of the affected pump (real time device parameters and setting recording file) was analyzed and revealed that on date of event the following error message was stored: 01.12.23!17:06:47.443 15=canap 50ah=control_stop 8 2, that suggests that the pump was wrongly linked to the cardioplegia module.Livanova is investigating if this is the root cause of the pump stop.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Based on the log files analysis and considering that the pump stopped without any alarm, it can be assumed that the arterial pump was wrongly linked to the cardioplegia module, consequently, it is highly probable that the cardioplegia bubble alarm stopped the arterial pump.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.
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 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 GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18407711
• Report Number: 9611109-2023-00661
• Device Sequence Number: 7201465
• Product Code: DTQ
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)181212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,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: 10-88-00
• 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: 12/02/2023
• Supplement Date Received by Manufacturer: 02/29/2024; 08/08/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/27/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2018
• 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