MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SRD S5 MAST ROLLER PUMP 150; 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	12/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the s5 mast roller pump.The incident occurred in japan.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 a mast roller pump 150 (brain separation blood transmission pump) stopped and displayed motor control failure error (e442) during bypass.After that, the case was concluded by using a hemoconcentration pump.There is no report of any patient injury.
Additional Manufacturer Narrative
Device was returned to livanova japan, tested and the issue was not reproducible.Serial read out (real time device parameters and setting recording file) of the pump was collected and sent to tssi for analysis.Investigation of the log is on-going.Initial analysis of the log confirmed the presence of the claimed error (e442 rc_no_pulse_block was in the log).Since the fact that an error was displayed, investigation was based on what it is recommended in the service manual following the displayed error from the content of error 442.The inside of the pump was checked and found that there was no abnormality in the movement of the motor.The motor control board (just to be safe) and after that confirmed again the device worked as expected.The pump cover was damaged during packaging, so it was replaced.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.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: through the pump serial read-out analysis it was also found that at around the same time of issue occurred (motor control failure error), another error code associated to maximum lead limit reached was stored in the pump microcontroller.This additional error code can be due to over-occlusion or wrong tubing.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 the outcome of pump serial read-out and technical service activity performed, it cannot be ruled out that the most likely root cause of the reported event was related to a user error that set the occlusion of the pump too tight, used wrong tubing or did not check the pump head for foreign objects before the procedure as indicated in the device instructions for use.

• Brand Name: SRD S5 MAST 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: 18510417
• Report Number: 9611109-2024-00031
• Device Sequence Number: 19749079
• Product Code: DWB
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)191023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062396
• 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): 03/13/2024

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: 10-88-00
• 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: 12/17/2023
• Supplement Date Received by Manufacturer: 01/09/2024; 02/15/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/06/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2019
• 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