MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SRD S5 SINGLE ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-80-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no known patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in kuwait.Motor power amplifier circuit board, motor controller circuit board and pump control panel with touch screen have been checked and found conforming.Livanova initiated an investigation.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, the single roller pump 150 displayed an motor control failure error (e#431) during installation.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: the affected part was returned to livanova deutschland for a detailed investigation.The technician could confirm the reported issue.In order to solve it, complete pump head was replaced and as preventive maintenance also the pump cover was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A device service history review has been performed and identified that the unit was manufactured in 2023 and no other similar event has been reported for this unit.Based on investigation results of similar complaints and as per service manual, motor control failure error (e431 code) can be due to: - pump resolver fixation loosened / resolver defective; - defective hms (motor control) board.Taking into account all collected information and technical intervention, the most likely root cause has been assigned to a loosened fixation of resolver inside the pump head.

• Brand Name: SRD S5 SINGLE 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: 19403918
• Report Number: 9611109-2024-00234
• Device Sequence Number: 6955922
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)230207
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K071318
• 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): 09/24/2024

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: 10-80-00
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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