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

Model Number 10-85-00

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

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

Event Date 01/25/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that the on/off push button of a s5 roller pump was defective since it tended to come loose.The issue occurred during maintenance activity.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 double head pump.The incident occurred in (b)(6) italy.Through follow-up communication livanova learned that the customer turns off the s5 system from the button present in the the ep (electronics and power) pack, instead of switch off the pump modules individually at the end of the procedure.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to fix it, on/off push button was replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

The affected roller pump was manufactured in 2016 and according to the complaints database review, no further issues have been submitted for this unit.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.Based on the above facts, it cannot be ruled out that a defective spring caused the reported malfunction.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: S5 DOUBLE HEAD 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: 16427044
• MDR Text Key: 310272338
• Report Number: 9611109-2023-00080
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)161208
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• 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