MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH 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	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, when switching on the s5 system, master pump alarm fault in the motor control (429).There is no report of any patient injury.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures s5 mast roller pump.A livanova field service representative was dispatched to the facility to investigate the device.Serial read out (real time device parameters and setting recording file) of the pump was collected form the master pump.To solve the issue, motor controller hms 0409 and hmf 0408, motor power amplifier board hmf 0408 were replaced.Clear nvmem of the pump and panel was performed.Software was updated to rev.4.1.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.This medwatch was initially submitted on 10 october 2024.The 3ack failed.The report is being resubmitted on 11 october 2024.
Additional Manufacturer Narrative
H11: the serial read-out of the roller pump (real-time device parameters and setting recording file) was gathered and analyzed.Error code 429 was confirmed when pump turned on from event stored: 11.09.24@09:25:39.244 c1=mcan 1adh=permanent_current_offset that indicates that the measured current value differs from setpoint.Motor control board (hms) board or flat ribbon cable connecting the hms to motor power amplifier board (hmf) board is defective and producing wrong signal.A device service history review has been performed and identified that the unit was manufactured in 2019 and no other similar event has been reported, neither concerning trend has been identified.Taking into account outcome of the technical service activity, the most likely root cause of the reported issue has been assigned to electrical failure of one or both of the replaced boards.
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 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: 20426232
• Report Number: 9611109-2024-00462
• Device Sequence Number: 8506431
• Product Code: DTQ
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)190607
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 12/12/2024

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: 10-88-00
• Was Device Available for Evaluation?: No
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2019
• 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