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

Model Number 10-80-00

Device Problem Failure to Power Up (1476)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Livanova (b)(4) received a report that a s5 roller pump stopped during priming and the push button switch did not work when attempting to restart the pump.There was no report of patient injury.

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility and the push button switch was replaced.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

H.10: through follow-up communication livanova learned that the date of event was march 9, 2022 and not march 10, 2022 as initially reported.The event date has been updated in the dedicated b section.Serial read out of the complained pump has been analyzed revealing the following: - the read out provided by livanova technician is the one of the pump used for cardioplegia delivering.- on march 9, 2022 in the time slot between 8-12 no anomalies occurred.The pump stopped due to stop- link function activated (the pump was linked to a master pump).Based on this result, it is likely that user tried to switch on the pump after it stopped because of the stop link function and it didn't turn on because the power switch didn't stay hooked.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: as anticipated in the previous supplemental report, based on investigation result, it is likely that user tried to switch on the pump after it stopped because of the stop link function and it didn't turn on because the power switch didn't stay hooked.The push button switch is a small, sealed mechanism that completes an electric circuit when it is pressed.When it is in the "on" position, a small metal spring inside makes contact with two wires, allowing electricity to flow.When it's off, the spring retracts, contact is interrupted, and current does not flow.If the switch does not properly latch, most likely is its internal spring to be faulty.

Event Description

See initial report.

• 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; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 14049937
• MDR Text Key: 288866373
• Report Number: 9611109-2022-00163
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)150818
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2015
• 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