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

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 roller pump gave a motor control failure error message and did not work.Customer replaced it with another one.The issue occurred during setup.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Motor control board (hms) was replaced and functional check on the pump was performed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

The read-out was analyzed and it was found that: - several instances of the message "15=canap 2a0h=overload_peak_current" were recorded.The previous message is recorded in case pump occlusion is too high or if the pump is being affected by mechanical issues; - three instances of the message "c0=mmain 1bah=no_pulse_block" were recorded.The previous message is recorded in case the pump stops after rotating because of an occlusion being set too high or something in the raceway blocks the pump.In the mentioned circumstance, there is a high current consumption by the pump and the alarm code 442 generally appears on the screen.A device service history review has been performed and identified that the unit was manufactured in 2018 and one previous similar event has been reported in 2022.Considering the information provided by the livanova representative who tested the pump, a mechanical problem with the pump has been ruled out to be a contributing factor to the event.Based on the evidence reported in the read-out, it is reasonable to assume that the customer faced a 442 motor control failure caused by a pump occlusion being set too high.The mentioned conclusion is in accordance with the fact that the livanova representative did not find any abnormalities with the pump during testing.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.This report was due on november 29, 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 immediately following restoration of the livanova systems.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17649177
• MDR Text Key: 322247408
• Report Number: 9611109-2023-00408
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)180323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1