MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150; 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	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, during check list of the hlm and prime procedure, the roller pump 150 displayed an error related to failure of the motor control (e431).Perfusionist tried to solve resetting the pump.The issue apperared some minutes after restart.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures s5 roller pump 150.The fse engineer has checked the pump and found problems with the motor control board hms0409 the fse interchanged this board with one of the another pump.This pump is out of service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H 11: the pump was installed in 2022 and no other similar events have been recorded.Furthermore, reviewing the database of complaints on hms board issues of manufactured pumps in 2022, no trend on this type of problem was recorded.Therefore, the event is isolated.Based on all the above, the most likely root cause of the reported event has been assigned to an electrical failure of the motor controller board.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro subcomponents.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: S5 ROLLER PUMP 150
• 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: 20531994
• Report Number: 9611109-2024-00499
• Device Sequence Number: 8324647
• Product Code: DTQ
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)221123
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 10-80-00Z
• Was Device Available for Evaluation?: Yes
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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