MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; 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	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in staten island, new york.Through follow-up communication with the customer, livanova learned that there was neither over-occlusion nor foreign object in the pump raceway.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue, after running for a while with tubing in raceway and water in tubing.In order to solve the issue, motor control (hms) board was replaced and motor power amplifier (hmf) board as a precaution measure.This report was due on november 22, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted following restoration of the livanova systems.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 s5 roller pump gave a motor control failure error message during procedure.After turning the pump off and on again the error message disappeared there was no patient injury.
Additional Manufacturer Narrative
H10: complaint database analysis revealed that the same pump has been claimed three months earlier for the same error code (mfr reference #(b)(4)).In that occasion, the motor control board (hms) was replaced as precaution, since the root cause was traced back to a pump occlusion being set too high.Based on the information collected, it cannot be ruled out that the re-occurrence of this claimed error code was still related to occlusion setting.The mentioned conclusion is in accordance with the fact that the livanova field service representative did not find any deviation with the pump during testing on site.
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.".
Event or Problem Description
See initial report.

• Brand Name: S5 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: 18299155
• Report Number: 9611109-2023-00626
• Device Sequence Number: 17930260
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)180323
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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 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: 10-80-00
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 02/29/2024; 08/08/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/25/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2018
• 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